Product Code: EBI FDA class 2 21 CFR 872.3760

Resin, Denture, Relining, Repairing, Rebasing

Dental

The Denture Relining, Repairing, and Rebasing Resin is a dental material used to restore the fit of an existing denture by adding or replacing the acrylic resin base, or to repair fractured denture components, extending the serviceable life of the prosthesis. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) clearance before marketing. The product code is EBI and the applicable regulation is 21 CFR 872.3760, under the Dental medical specialty. This device is eligible for third-party 510(k) review.

View on FDA

510(k)s

330

FEI Numbers

166

Registration Numbers

166

Unique Applicants

169

Years Active

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Basic Information

Product Code: EBI
Device Class: FDA class 2
Regulation Number: 872.3760
Medical Specialty: Dental
Review Panel: DE
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 330 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K260569	DB 4000 High Impact Denture Base	Jun 02, 2026	Substantially Equivalent	Carbon, Inc.
K260376	Denture Base	May 06, 2026	Substantially Equivalent	Shandong Huge Dental Material Corporation
K253365	LuxCreo Flexible Partial Denture Resin	Nov 25, 2025	Substantially Equivalent	LuxCreo, Inc.
K253681	TERA HARZ Hard Denture (THD-C-500); TERA HARZ Hard Denture (THD-C-1000); TERA HARZ Hard Denture (THD-LP-500); TERA HARZ Hard Denture (THD-LP-1000); TERA HARZ Hard Denture (THD-P-500); TERA HARZ Hard Denture (THD-P-1000); TERA HARZ Hard Denture (THD-CP-500); TERA HARZ Hard Denture (THD-CP-1000)	Nov 21, 2025	Substantially Equivalent	Graphy, Inc.
K253324	UltraPrint-Dental Denture UV	Nov 20, 2025	Substantially Equivalent	Guangzhou Heygears IMC., Inc.
K252430	Freeprint® denture flex	Oct 30, 2025	Substantially Equivalent	Detax GmbH
K252035	DENTURE SOFT EX (Pink set); DENTURE SOFT EX (White set); DENTURE SOFT EX (Pink powder); DENTURE SPFT EX (White powder); DENTURE SOFT EX (Liquid); DENTURE SOFT EX (Trial kit Pink); DENTURE SOFT EX (Trial kit White)	Sep 17, 2025	Substantially Equivalent	Kamemizu Chemical Industry Co., Ltd.
K250302	Flexible Partial Resin	Jun 25, 2025	Substantially Equivalent	Prismatik Dentalcraft, Inc.
K242897	Partial Flex	Jun 03, 2025	Substantially Equivalent	Clemde SA DE CV
K250489	FP3D	May 20, 2025	Substantially Equivalent	Keystone Industries
K250617	Apex Flex	Apr 29, 2025	Substantially Equivalent	Sprintray, Inc.
K243356	Asiga DentaBASE	Apr 11, 2025	Substantially Equivalent	Asiga Pty, Ltd.
K250946	Denture Base Resin DT20	Mar 31, 2025	Substantially Equivalent	Hangzhou SHINING3D Dental Technology Co., Ltd.
K243103	Denture Base	Dec 23, 2024	Substantially Equivalent	Riton 3D Technology Co., Ltd.
K243336	Lucitone Digital Print Denture System	Dec 17, 2024	Substantially Equivalent	Dentsply Sirona, Inc.
K242884	Additively Manufactured Denture Resin	Nov 22, 2024	Substantially Equivalent	Aidite (Qinhuangdao) Technology Co., Ltd.
K241089	KeyPrint KeyDenture Base	Oct 24, 2024	Substantially Equivalent	Keystone Industries
K241493	Glidewell 3DP Denture Base Resin	Sep 12, 2024	Substantially Equivalent	Prismatik Dentalcraft, Inc.
K241071	NextDent Jet Denture Base; NextDent Jet Denture Teeth	Sep 04, 2024	Substantially Equivalent	Vertex-Dental B.V.
K240688	RODIN Titan 3D Resin	Jun 20, 2024	Substantially Equivalent	Belport Company, Inc., Gingi-Pak
K233859	BASIS FLOW II	Mar 05, 2024	Substantially Equivalent	YAMAHACHI DENTAL MFG., Co.
K233995	Ivotion Base Print	Feb 23, 2024	Substantially Equivalent	Ivoclar Vivadent, Inc.
K233171	PF Keep; Cad Cam Keep Block	Nov 27, 2023	Substantially Equivalent	Clemde SA DE CV
K231578	Lucitone Digital Print Denture System	Oct 20, 2023	Substantially Equivalent	Dentsply Sirona
K231388	NextDent Base	Oct 20, 2023	Substantially Equivalent	Vertex-Dental B.V.
K232691	Polibond	Sep 05, 2023	Substantially Equivalent	Zirkonzahn Srl
K231389	Harvest Dental HD Gum Strip	Aug 16, 2023	Substantially Equivalent	Harvest Dental Products, LLC
K230445	OnX Tough	Jul 14, 2023	Substantially Equivalent	Sprintray, Inc.
K230410	DD medical polymers (PMMA)	Jun 23, 2023	Substantially Equivalent	Dental Direkt GmbH
K222489	Harvest Printable Resin	May 12, 2023	Substantially Equivalent	Harvest Dental Products, LLC
K230098	Trusana	Apr 13, 2023	Substantially Equivalent	Myerson, LLC
K230341	ACRIFIX	Apr 06, 2023	Substantially Equivalent	Deltamed GmbH
K230115	Denture Base Resin	Mar 17, 2023	Substantially Equivalent	Aidite (Qinhuangdao) Technology Co., Ltd.
K220042	Dentca Base Premium, Dentca Base Hi-Impact	Nov 17, 2022	Substantially Equivalent	Dentca, Inc.
K221678	SprintRay High Impact Denture Base	Nov 10, 2022	Substantially Equivalent	Sprintray, Inc.
K220236	V-Print dentbase	Sep 21, 2022	Substantially Equivalent	Voco GmbH
K220979	SprintRay Denture Base	Sep 14, 2022	Substantially Equivalent	Sprintray, Inc.
K220680	Denture Base Polymers	Aug 12, 2022	Substantially Equivalent	Shandong Huge Dental Material Corporation
K222414	TERA HARZ DENTURE	Aug 11, 2022	Substantially Equivalent	Graphy, Inc.
K220771	Stratasys TrueDent	Jul 07, 2022	Substantially Equivalent	Stratasys, Ltd.
K220743	CediTEC	Jul 05, 2022	Substantially Equivalent	Voco GmbH
K213765	Glidewell 3DP Denture Base Resin	Jun 22, 2022	Substantially Equivalent	Prismatik Dentalcraft, Inc.
K213994	Flexible Block	Mar 04, 2022	Substantially Equivalent	Shandong Huge Dental Material Corporation
K212541	3Delta Denture Base - 3Delta Denture Bond - 3Delta Denture Fix	Jan 10, 2022	Substantially Equivalent	Deltamed GmbH
K210189	Pac-Dent Denture Base Resin	Jul 28, 2021	Substantially Equivalent	Pac-Dent, Inc.
K210298	GR-14 Resin System	May 05, 2021	Substantially Equivalent	Pro3Dure Medical GmbH
K203641	E-Denture Pro	Mar 30, 2021	Substantially Equivalent	Envisiontec GmbH
K210828	DIOnavi-Denture02	Mar 23, 2021	Substantially Equivalent	Dio Corporation
K200580	FotoDent denture	Nov 19, 2020	Substantially Equivalent	Dreve Dentamid GmbH
K200461	Freeprint denture	Nov 16, 2020	Substantially Equivalent	Detax GmbH & Co. KG
K193623	DIOnavi-Denture	Oct 22, 2020	Substantially Equivalent	Dio Corporation
K191591	BB Base 3D printing resin for denture base	Aug 18, 2020	Substantially Equivalent	Enlighten Materials Co., Ltd.
K190790	Flex Fit	Jul 31, 2020	Substantially Equivalent	Dk Mungyo Corporation
K191926	VITA VIONIC Bond	Jan 29, 2020	Substantially Equivalent	Vita Zanhnfabrik H. Rauter GmbH Co.
K191497	NextDent Denture 3D+	Nov 01, 2019	Substantially Equivalent	Vertex-Dental B.V.
K190940	Tokuyama Rebase III	Oct 04, 2019	Substantially Equivalent	Tokuyama Dental Corporation
K191427	Halley resin system	Aug 26, 2019	Substantially Equivalent	Dentsply Sirona
K190043	Halley resin	Apr 24, 2019	Substantially Equivalent	Dentsply Sirona
K181331	JUVORA Oyster White Dental Disc, CERAMILL PEEK by JUVORA, Oyster White	Dec 21, 2018	Substantially Equivalent	Juvora, Ltd.
K182422	Lucitone Denture Base Materials	Dec 18, 2018	Substantially Equivalent	Dentsply Sirona
K181220	Juell 3D Volo Base	Oct 12, 2018	Substantially Equivalent	Park Dental Research Corporation
K172764	Keymill	Apr 27, 2018	Substantially Equivalent	Mycone Dental Supply Company, Inc. (Aka Keystone Industries)
K172683	Yamahachi Pink CAD/CAM Disk	Jan 16, 2018	Substantially Equivalent	YAMAHACHI DENTAL MFG., Co.
K172407	Duracetal	Nov 02, 2017	Substantially Equivalent	The Myerson Company Limited
K170375	Nobilplast Denture Resin	Oct 02, 2017	Substantially Equivalent	Cmp Industries, LLC
K170549	TOKUYAMA CUREGRACE	Jul 05, 2017	Substantially Equivalent	Tokuyama Dental Corporation
K162572	NextDent Denture, E-Denture	Jun 30, 2017	Substantially Equivalent	Vertex-Dental B.V.
K163482	Orthodontic Acrylic 2	May 31, 2017	Substantially Equivalent	Lang Dental Manufacturing Co., Inc.
K162654	mollosil plus	Mar 13, 2017	Substantially Equivalent	Detax GmbH & Co. KG
K162044	Dentca Denture Base II	Mar 03, 2017	Substantially Equivalent	Dentca, Inc.
K160918	JUVORA Dental Disc, Ceramill PEEK by JUVORA	Feb 13, 2017	Substantially Equivalent	Juvora
K161330	Pour Acrylic	Oct 06, 2016	Substantially Equivalent	Dentsply Sirona
K153546	PINK CAD/CAM disc	Sep 28, 2016	Substantially Equivalent	Polident D.O.O., Dental Products Industry
K152981	JET SET 4 DENTURE REPAIR RESIN	Sep 02, 2016	Substantially Equivalent	Lang Dental Manufacturing Company, Inc.
K160498	Dentivera Milling Disc	Jun 15, 2016	Substantially Equivalent	Dental Solutions, LLC
K153590	AvaDent Denture Base Material	Apr 22, 2016	Substantially Equivalent	Global Dental Science
K152051	ClearMet	Mar 22, 2016	Substantially Equivalent	Mycone Dental Supply Co., T/A Keystone Industries
K153253	GC Reline II	Mar 03, 2016	Substantially Equivalent	GC America, Inc.
K152270	Denture base resin	Nov 13, 2015	Substantially Equivalent	Korea Engineering Plastics Co., Ltd.
K151646	ProTech Plus	Oct 21, 2015	Substantially Equivalent	Protech Professional Products, Inc.
K151142	IVOBASE CAD FOR ZENOTEC, IVOBASE CAD BOND, IVOBASE CAD MODELLING LIQUID	Aug 13, 2015	Substantially Equivalent	Wieland Dental + Technik GmbH & Co. KG
K143033	DENTCA DENTURE BASE	Jul 21, 2015	Substantially Equivalent	Dentca, Inc.
K150511	Coating Material	May 27, 2015	Substantially Equivalent	Sun Medical Co., Ltd.
K150454	Acryfree Denture Base Material and Biosens Denture Base Material	May 26, 2015	Substantially Equivalent	Perflex
K143265	Acrylic Block	Apr 14, 2015	Substantially Equivalent	Sun Medical Co., Ltd.
K142894	TCS Blend	Feb 03, 2015	Substantially Equivalent	Thermoplastic Comfort Systems, Inc.
K143486	Ufi Gel hard C	Jan 07, 2015	Substantially Equivalent	Voco GmbH
K140758	M-PM-DISC (PINK)	Sep 15, 2014	Substantially Equivalent	Merz Dental GmbH
K141439	ORTHODONTIC ACRYLIC (NOT FINALIZED)	Sep 12, 2014	Substantially Equivalent	Bisco, Inc.
K140570	CHAIRSIDE ATTACHMENT PROCESSING MATERIAL	Jun 16, 2014	Substantially Equivalent	Zest Anchors, LLC
K140146	COMFORTSOFT SOFT DENTURE LINER SYSTEM	Apr 29, 2014	Substantially Equivalent	Whip Mix Corp.
K132725	JUVORA DENTQAL DISC	Jan 23, 2014	Substantially Equivalent	Juvora
K130076	PROMOLUX, PROMOLUX HI, WEROPRESS, PREMECO PCS	Aug 22, 2013	Substantially Equivalent	Merz Dental GmbH
K130680	ACRYTONE, REZEN NF, AND ISO FAST DENTURE RESINS	Jul 26, 2013	Substantially Equivalent	Dentsoll, Inc.
K131036	YAMAHACHI DENTURE BASE RESINS	Jul 12, 2013	Substantially Equivalent	Yamahachi Dental Manufacturing Co.
K123220	VERTEX THERMOSENS RIGID	Mar 01, 2013	Substantially Equivalent	Vertex-Dental B.V.
K123396	I.FLEX BY TCS	Jan 10, 2013	Substantially Equivalent	Thermoplastic Comfort Systems, Inc.
K122348	QUARTZ SPLINT SYSTEM (UD, WOVEN, ROPE, MESH) QUARTZ SPINT RESIN QS FLOW	Oct 15, 2012	Substantially Equivalent	Recherches Techniques Dentaires (R.T.D.)
K113608	DEFLEX	Apr 10, 2012	Substantially Equivalent	Nuxen S.R.L.
K113788	DEFLEX ACRILATO	Mar 16, 2012	Substantially Equivalent	Nuxen S.R.L.
K111709	FOUNDATION DENTAL RESIN	Nov 18, 2011	Substantially Equivalent	Unix-Japan Co., Ltd.
K112397	ORTHO-JET CRYSTAL	Nov 04, 2011	Substantially Equivalent	Lang Dental Mfg. Co., Inc.
K112445	SOFRELINER TOUGH S	Oct 28, 2011	Substantially Equivalent	Tokuyama Dental Corporation
K111832	PALADON ULTRA POWDER (PINK), PALADON ULTRA LIQUID	Sep 29, 2011	Substantially Equivalent	Heraeus Kulzer, LLC
K111178	JUELL SOFT CURE	Sep 12, 2011	Substantially Equivalent	Juell Dental
K111177	JUELL HARD CURE	Sep 12, 2011	Substantially Equivalent	Juell Dental
K110440	QUICK UP	May 04, 2011	Substantially Equivalent	Voco GmbH
K110037	PALAXPRESS ULTRA POWDER (PINK); PALAXPRESS ULTRA LIQUID	Apr 29, 2011	Substantially Equivalent	Heraeus Kulzer, LLC
K102874	NEW STETIC ACRYLICS	Mar 28, 2011	Substantially Equivalent	New Stetic
K102640	VERTEX SELF CURING, VERTEX CASTAVARIA, VERTEX CASTAPRESS	Mar 25, 2011	Substantially Equivalent	Vertex-Dental B.V.
K103391	IVOBASE HYBRID, IVOBASE HIGH IMPACT	Feb 17, 2011	Substantially Equivalent	Ivoclar Vivadent, Inc.
K102654	VERTEX RAPID SIMPLIFIED	Dec 03, 2010	Substantially Equivalent	Vertex-Dental B.V.
K102207	FIBER FORCE	Nov 23, 2010	Substantially Equivalent	Synca Marketing, Inc.
K102347	GRANDTEC	Oct 29, 2010	Substantially Equivalent	Voco GmbH
K100653	JET XR RADIOPAQUE ACRYLIC RESIN POWDER 45 GRAMS, JET XR RADIOPAQUE ACRYLIC RESIN POWDER 100 GRAMS, JET LIQUID 118 ML MOD	Oct 08, 2010	Substantially Equivalent	Lang Dental Mfg. Co., Inc.
K081554	TOKUYAMA TISSUECARE	Mar 18, 2009	Substantially Equivalent	Tokuyama Dental Corporation
K083479	BIOCRYL X	Feb 27, 2009	Substantially Equivalent	Great Lakes Orthodontics, Ltd.
K081537	CFS FLEXIBLE	Jan 22, 2009	Substantially Equivalent	Comfort and Flexible Systems
K082180	PERMA FIBER,MODEL 441; PERMA MESH, MODEL 440	Dec 17, 2008	Substantially Equivalent	Angelus Industria DE Productos Odontologicos
K082153	MAJOR.REPAIR	Nov 25, 2008	Substantially Equivalent	Major Prodotti Dentari S.P.A.
K081981	LANG DENTAL ACRYLIC PRIMER	Nov 17, 2008	Substantially Equivalent	Lang Dental Mfg. Co., Inc.
K081884	MAJOR.BASE 20	Oct 08, 2008	Substantially Equivalent	Major Prodotti Dentari S.P.A.
K081514	TEMPO CUSHION TREATMENT DENTURE RELINE ACRYLIC RESIN LIQUID, PROFESSIONAL SIZE PACKAGE AND POWDER	Sep 22, 2008	Substantially Equivalent	Lang Dental Mfg. Co., Inc.
K072851	POLYSTAR 79 DENTURE BASE RESIN	Feb 20, 2008	Substantially Equivalent	Cmp Industries, LLC
K073040	SMH FLEX S	Dec 13, 2007	Substantially Equivalent	Smh Biomaterial AG
K072479	FLEXITE SUPREME, FLEXITE PLUS, FLEXITE M.P., NORTHERN AND FLEXITE PRO-GUARD	Nov 09, 2007	Substantially Equivalent	Rapid Injection Systems Corp.
K072580	JET DENTURE REPAIR POWDER MEHARRY 100,454 GRAMS, JET DENTURE REPAIR PROFESSIONAL PACKAGE 100 GRAMS/118ML, 1220,30,23	Nov 05, 2007	Substantially Equivalent	Lang Dental Mfg. Co., Inc.
K072402	FLEX-STAR V	Oct 19, 2007	Substantially Equivalent	Cmp Industries, LLC
K072713	ION DENTAL RESIN SYSTEM	Oct 12, 2007	Substantially Equivalent	Dentsply International, Inc.
K071245	TALON AND REVERE	Aug 02, 2007	Substantially Equivalent	Talon Acrylics, Inc.
K070698	COE COMFORT	Mar 29, 2007	Substantially Equivalent	GC America, Inc.
K070697	COE SOFT	Mar 29, 2007	Substantially Equivalent	GC America, Inc.
K063626	DURAFLEX	Feb 08, 2007	Substantially Equivalent	Cosmetic Dental Materials, Inc.
K063170	TENDER FIBER	Jan 12, 2007	Substantially Equivalent	Micerium S.P.A.
K061735	INFIBRA, MODEL 1200	Sep 08, 2006	Substantially Equivalent	Global Dental Products, Inc.
K061580	ECLIPSE WAX REMOVER	Jul 28, 2006	Substantially Equivalent	Dentsply International
K061501	FLEXO DENTAL RESIN MATERIAL	Jul 26, 2006	Substantially Equivalent	Aci, Inc.
K053060	TCS UNBREAKABLE	Jul 20, 2006	Substantially Equivalent	Thermoplastic Comfort Systems, Inc.
K060844	SILKLINE SOFT RELINING KIT, MODEL 28-100100	Jun 06, 2006	Substantially Equivalent	J. Morita USA, Inc.
K053516	MUCOHARD	Jan 26, 2006	Substantially Equivalent	Parkell, Inc.
K053328	BIOSPLINT SPLINTING RIBBON	Jan 25, 2006	Substantially Equivalent	Satelec
K052780	DENTAPLAST HOT, MODEL 16-XXX	Dec 21, 2005	Substantially Equivalent	Bredent-Products For the Dental Technician Laborat
K052073	FUTURAPRESS LT, N AND HP, FUTURAJET, FUTURASELF, FUTURAGEN AND FUTURACRYL 2000	Oct 26, 2005	Substantially Equivalent	Schutz-Dental GmbH
K051358	NATURE-CRYL HI PLUS	Jul 07, 2005	Substantially Equivalent	GC America, Inc.
K043504	PALAIMPACT	Jan 28, 2005	Substantially Equivalent	Heraeus Kulzer, Inc.
K043295	VERSYO.DIRECT	Jan 05, 2005	Substantially Equivalent	Heraeus Kulzer, Inc.
K042931	TUF LINK SILICONE RELINER	Dec 08, 2004	Substantially Equivalent	Dentatus USA , Ltd.
K040881	METACRYL	May 25, 2004	Substantially Equivalent	Great Lakes Orthodontics, Ltd.
K034024	TESCERA FIBER BUNDLES, FIBER MESH AND FIBER CYLINDERS	Mar 19, 2004	Substantially Equivalent	Bisco, Inc.
K033632	VARIFLEX	Jan 21, 2004	Substantially Equivalent	Great Lakes Orthodontics, Ltd.
K033472	TESCERA U-BAR AND BARRELS	Jan 15, 2004	Substantially Equivalent	Bisco, Inc.
K033629	VERSYO.BOND	Dec 22, 2003	Substantially Equivalent	Heraeus Kulzer, Inc.
K033020	IMPAK ACRYLIC REPAIR RESIN LIQUID	Dec 19, 2003	Substantially Equivalent	Cmp Industries, LLC
K032892	MODIFICATION TO TRUBYTE DENTURE BASE RESIN SYSTEM	Sep 26, 2003	Substantially Equivalent	Dentsply Intl.
K032773	DIAMOND D HIGH IMPACT DENTURE ACRYLIC	Sep 23, 2003	Substantially Equivalent	Mycone Dental Supply Co., Inc.
K031070	CARBON FIBER BRIDGE, MODEL 28757	Jul 03, 2003	Substantially Equivalent	Nobel Biocare AB
K030916	UFI GEL HARD C	Jun 19, 2003	Substantially Equivalent	Voco GmbH
K030663	TOKUYAMA SOFRELINER TOUGH	May 29, 2003	Substantially Equivalent	Tokuyama Dental Corporation
K030072	EVERSTICK PERIO	Apr 10, 2003	Substantially Equivalent	Stick Tech , Ltd.
K022641	TOKUYAMA REBASE II	Oct 02, 2002	Substantially Equivalent	Tokuyama America, Inc.
K021437	SECURE SOFT	Jul 19, 2002	Substantially Equivalent	Imtec Corp.
K021586	SECURE RELINE/PICKUP MATERIAL	Jun 14, 2002	Substantially Equivalent	Imtec Corp.
K021121	AROMACRYL	May 28, 2002	Substantially Equivalent	Aromacryl, LLC
K021126	EVERSTICK ORTHO	May 13, 2002	Substantially Equivalent	Stick Tech , Ltd.
K013881	RIBBOND - TRIAXIAL	Jan 25, 2002	Substantially Equivalent	Ribbond, Inc.
K012882	BITEM ANGEL RELINE KIT, BITEM LABORATORY KIT, MODELS 120110, 120060	Nov 14, 2001	Substantially Equivalent	Thermoelastic Technologies, Inc.
K011799	EVERSTICKNET	Nov 05, 2001	Substantially Equivalent	Stick Tech , Ltd.
K011788	EVERSTICK	Nov 05, 2001	Substantially Equivalent	Stick Tech , Ltd.
K011820	DENTORIUM CONVERTIBLE ACRYLIC	Sep 05, 2001	Substantially Equivalent	Nats Corp.
K011762	HI-WAVE; POUR-PLUS	Aug 23, 2001	Substantially Equivalent	Denplus, Inc.
K011560	TRUBYTE DENTURE BASE RESIN SYSTEM	Jul 12, 2001	Substantially Equivalent	Dentsply Intl.
K011277	HARD RELINER	Jun 26, 2001	Substantially Equivalent	S & C Polymer GmbH
K010800	VERSYO.COM	May 31, 2001	Substantially Equivalent	Heraeus Kulzer, Inc.
K003334	STICK NET	Jan 08, 2001	Substantially Equivalent	Stick Tech , Ltd.
K003333	STICK	Jan 04, 2001	Substantially Equivalent	Stick Tech , Ltd.
K002048	JBC OPAQUE AND GLITTER	Aug 30, 2000	Substantially Equivalent	J.B.C and Co.
K001640	BIOSOFT RESIN	Jun 23, 2000	Substantially Equivalent	Biosoft International Corp.
K001463	SCHOTTLANDER ENIGMA COLOUR TONE, MODEL 0156	Jun 16, 2000	Substantially Equivalent	Davis Schottlander & Davis, Ltd.
K992176	EXCEL ULTRA-HI FORMULA HEAT-CURED DENTURE BASE MATERIAL	Feb 10, 2000	Substantially Equivalent	St. George Technology, Inc.
K993827	UFI GEL HARD	Jan 20, 2000	Substantially Equivalent	Voco GmbH
K993717	ENIGMA HI-BASE DENTURE BASE MATERIAL	Dec 22, 1999	Substantially Equivalent	Davis Schottlander & Davis, Ltd.
K991687	MODIFICATION TO LINER II: SOFT RELINE LIQUID	Oct 07, 1999	Substantially Equivalent	Bosworth Co.
K992956	LUCITONE FRS FLEXIBEL DENTAL RESIN	Oct 06, 1999	Substantially Equivalent	Dentsply Intl.
K992609	HYDRO-CAST SILICONE SOFT-LINER, MODEL 68400	Sep 22, 1999	Substantially Equivalent	Kay See Dental Mfg. Co.
K991577	NIC TONE ACRYLIC RESINS	Sep 22, 1999	Substantially Equivalent	Manufacturera Dental Continental
K991996	IMPACT-PLUS, IMPACT-20, DP97, DP97-20, DP-POUR AND DP-REPAIR	Sep 08, 1999	Substantially Equivalent	Denplus, Inc.
K991774	ACRON MC MODIFICATION	Jul 09, 1999	Substantially Equivalent	GC America, Inc.
K990736	GC RELINE SOFT/EXTRA SOFT	May 28, 1999	Substantially Equivalent	GC America, Inc.
K990763	VITRON M	May 25, 1999	Substantially Equivalent	Espe Dental AG
K991220	VITRON H	May 20, 1999	Substantially Equivalent	Espe Dental AG
K990699	ORTHO-GLOW GLITTER	May 17, 1999	Substantially Equivalent	Harry J. Bosworth Co.
K983461	UNI-FLEX RESIN	Apr 13, 1999	Substantially Equivalent	Trans-Atlantic Dental
K990056	JELDENT MULTICRYL	Mar 25, 1999	Substantially Equivalent	J.F. Jelenko & Co., Inc.
K990448	THE.R.MO.FREE	Mar 23, 1999	Substantially Equivalent	Dentamax, Inc.
K984365	GC UNIFAST TRAD	Feb 25, 1999	Substantially Equivalent	GC America, Inc.
K984467	FUSICRYL	Feb 24, 1999	Substantially Equivalent	Micro Dental Laboratories
K984483	A-SOFT RELINER	Feb 18, 1999	Substantially Equivalent	S & C Polymer GmbH
K981862	RESIN 4	Feb 09, 1999	Substantially Equivalent	Harry J. Bosworth Co.
K984341	STERNVANTAGE VARNISH LC, MODEL 221001	Jan 08, 1999	Substantially Equivalent	Sterngold/Implamed
K983547	PROTECH PLUS	Jan 07, 1999	Substantially Equivalent	Protech, Inc.
K983876	MILLENIUM SLEDGEHAMMER, FORMULA 99 AND NATURALYKE H.C., HIGH IMPACT DENTURE ACRYLIC	Dec 16, 1998	Substantially Equivalent	Mycone Dental Supply Co., Inc. (A/K/A Keystone Ind
K983357	MUCOPREN SOFT RELINING SYSTEM	Nov 13, 1998	Substantially Equivalent	Roydent Dental Products, Inc.
K981691	SILICONE SOFT RELINE	Nov 03, 1998	Substantially Equivalent	Harry J. Bosworth Co.
K982695	GC RELINE	Oct 19, 1998	Substantially Equivalent	GC America, Inc.
K981861	LINER 1:HARD RELINE LIQUID	Oct 01, 1998	Substantially Equivalent	Harry J. Bosworth Co.
K982537	TOKUYAMA SOFRELINER	Aug 24, 1998	Substantially Equivalent	Tokuyama America, Inc.
K981448	KERR HARD DENTURE RELINE MATERIAL	Jun 16, 1998	Substantially Equivalent	Sybron Dental Specialties, Inc.
K980616	PERMAFIX CHAIRSIDE SOFT DENTURE RELINING (7010) (7011-13) (7014-15)	Apr 30, 1998	Substantially Equivalent	Kohler Medizintechnik GmbH & Co. KG
K974865	CSR	Mar 16, 1998	Substantially Equivalent	Parkell, Inc.
K974160	BRUXTRAK MATERIAL	Mar 11, 1998	Substantially Equivalent	Bruxcare, LLC
K974727	JET ACRYLIC LIQUID-MONOMER, ORTHO JET POWDER-POLYMER, PLASTICIZED METHACRYLATE HOMOPOLYMER, METHACRYLATE COPOLYMER, METR	Feb 24, 1998	Substantially Equivalent	J.B.C and Co.
K974772	UFI GEL C	Feb 10, 1998	Substantially Equivalent	Voco GmbH
K973542	MASKY	Feb 10, 1998	Substantially Equivalent	Pressing DI Monticelli Rag. Stefano
K972553	LANG DENTAL RESIN A97 FIBRED PINK	Nov 13, 1997	Substantially Equivalent	Lang Dental Mfg. Co., Inc.
K972573	LIQCRYLIC PRO DENTAL RESIN	Sep 16, 1997	Substantially Equivalent	Dentsply Intl.
K971138	DINABASE (TM)	Jul 21, 1997	Substantially Equivalent	Sultan Chemists, Inc.
K970522	MYERSON'S ECONOMY DENTURE BASE MATERIAL	May 14, 1997	Substantially Equivalent	Austenal, Inc.
K964040	TRUBYTE SOFT RELINE SYSTEM	Dec 06, 1996	Substantially Equivalent	Dentsply Intl.
K963736	SOFT DENTURE REBASING RESIN	Dec 04, 1996	Substantially Equivalent	Sybron Dental Specialties, Inc.
K963144	GC BASELINE	Oct 29, 1996	Substantially Equivalent	GC America, Inc.
K962333	V.R.S. DENTURE RESIN MATERIAL	Aug 07, 1996	Substantially Equivalent	Vident
K962374	FIBER-SPLINT ML MULTILAYER	Jul 22, 1996	Substantially Equivalent	Polydentia USA
K961995	QUICKSPLINT	Jun 26, 1996	Substantially Equivalent	Heraeus Kulzer, Inc.
K961200	BOSWORTH LIQUID RESIN II	May 17, 1996	Substantially Equivalent	Harry J. Bosworth Co.
K953589	TOKUYAMA SOFT RELINING	Jan 18, 1996	Substantially Equivalent	Tokuyama America, Inc.
K954637	AMERICAN DENTAL PRODUCTS TISSUE CONDITIONER & TEMPORARY RELINER	Dec 28, 1995	Substantially Equivalent	American Dental Products, Inc.
K954810	MYERSON IR DENTURE BASE	Nov 29, 1995	Substantially Equivalent	Austenal, Inc.
K954689	CONNECT	Oct 30, 1995	Substantially Equivalent	Sybron Dental Specialties, Inc.
K953743	PALASPLINT	Oct 02, 1995	Substantially Equivalent	Heraeus Kulzer, Inc.
K953381	PROP. CONQUEST C&B VLC GLAZE/SEALANT	Sep 27, 1995	Substantially Equivalent	Jeneric/Pentron, Inc.
K953119	BOSWORTH RESIN II	Aug 28, 1995	Substantially Equivalent	Bosworth Co.
K952351	PRECISE DENTURE BASE RESIN	Jul 07, 1995	Substantially Equivalent	Dentsply Intl.
K944466	SEALDENT	Mar 02, 1995	Substantially Equivalent	Scientific Pharmaceuticals, Inc.
K943905	PRO-CRYLIC RESIN, TECHNICOLOR PRE-MIX MONOMER	Feb 27, 1995	Substantially Equivalent	Professional Positioners, Inc.
K946317	HARRY J. BOSWORTH RESIN I.	Feb 16, 1995	Substantially Equivalent	Harry J. Bosworth Co.
K945711	EXCEL-P FORMULA AUTO-CURE DENTURE BASE	Feb 02, 1995	Substantially Equivalent	St. George Technology, Inc.
K942562	PROSTHOFLEX	Dec 20, 1994	Substantially Equivalent	Knopf Assoc, Inc.
K941925	ORTHO-JET ACRYLIC RESIN - SPARKLE	May 27, 1994	Substantially Equivalent	Lang Dental Mfg. Co., Inc.
K940565	COE-SOFT LC	May 04, 1994	Substantially Equivalent	GC America, Inc.
K935261	KOOLINER II	Jan 26, 1994	Substantially Equivalent	GC America, Inc.
K930939	REBARON LC	Jan 21, 1994	Substantially Equivalent	GC America, Inc.
K934019	EXCEL FORMULA HEAT-AUTO CURE DENT BASE/REPAIR/ORTHO	Jan 18, 1994	Substantially Equivalent	St. George Technology, Inc.
K933468	MYERSON'S PERMASOFT SOFT RELINE MATERIAL	Jan 05, 1994	Substantially Equivalent	Austenal, Inc.
K934248	ALPHA-DENT TISSUE CONDITIONER AND TEMPORARY RELINER	Dec 08, 1993	Substantially Equivalent	Wallace A. Erickson & Co.
K933831	PERMASOFT SOFT RELINE MATERIAL BY NU-DENT, INC.	Dec 06, 1993	Substantially Equivalent	Nu-Dent, Inc.
K926406	DUAL CURE RELINE MATERIAL	Mar 31, 1993	Substantially Equivalent	Dentsply Intl.
K925062	PERMAFLEX PERMANENT SOFT DENTURE RELINER	Mar 31, 1993	Substantially Equivalent	Protech Professional Products, Inc.
K925275	SOFT DENTURE RELINE MATERIAL ELASTOLINE	Jan 11, 1993	Substantially Equivalent	Great Lakes Orthodontics, Ltd.
K924422	PALABOND	Nov 04, 1992	Substantially Equivalent	Heraeus Kulzer, Inc.
K915898	PALADUR	Sep 16, 1992	Substantially Equivalent	Heraeus Kulzer, Inc.
K912990	CONVERBASE	Mar 25, 1992	Substantially Equivalent	Wilde-USA, Inc.
K920557	WIL-O-DONT ORTHODONTIC MATERIAL/WIL-O-LUX	Mar 20, 1992	Substantially Equivalent	Wilde-USA, Inc.
K912993	WILDE DENTURE RESINS	Feb 03, 1992	Substantially Equivalent	Wilde-USA, Inc.
K915377	SR-IVOCAP PLUS	Jan 31, 1992	Substantially Equivalent	Ivoclar North America, Inc.
K912991	WILDE AUXILIARIES	Dec 19, 1991	Substantially Equivalent	Wilde-USA, Inc.
K913655	PROBASE HOT AND PROBASE COLD	Oct 17, 1991	Substantially Equivalent	Ivoclar North America, Inc.
K913699	MODERN MATERIALS ORTHODONTIC RESIN	Oct 09, 1991	Substantially Equivalent	Heraeus Kulzer, Inc.
K913698	ACCELAR 20 ADVANCE RAPID CURE REPAIR MATERIAL	Oct 09, 1991	Substantially Equivalent	Heraeus Kulzer, Inc.
K913040	RIBBOND(TM)	Oct 07, 1991	Substantially Equivalent	Ribbond, Inc.
K910795	COMFOR-DENT DENTURE LINER	Jul 11, 1991	Substantially Equivalent	Comfort Acrylics Co.
K910465	MELIODENT, DENTURE RESIN	Jun 06, 1991	Substantially Equivalent	Heraeus Kulzer, Inc.
K905702	NEW TRIAD TRANSHEET DENTURE BASE MATERIAL	Apr 29, 1991	Substantially Equivalent	Dentsply Intl.
K902972	FLEXOR (DENTURE ACRYLIC RELINE MATERIAL)	Oct 04, 1990	Substantially Equivalent	Cmp Industries, LLC
K902115	PALAPRESS(R) VARIO RESIN	Jul 27, 1990	Substantially Equivalent	Kulzer, Inc.
K901621	NEW PER-FIT(R) IMPROVED	Jun 26, 1990	Substantially Equivalent	Dental Product Co.
K901789	PALADON(R) 65	Jun 22, 1990	Substantially Equivalent	Kulzer, Inc.
K900799	COMFORT ACRYLICS PLIABLE DENTURE LINERS & SPLINTS	May 15, 1990	Substantially Equivalent	Comfort Acrylics Co.
K900301	NOVUS BONDING AGENT	May 15, 1990	Substantially Equivalent	The Hygenic Corp.
K896981	TOKUSO REBASE	May 15, 1990	Substantially Equivalent	Tokuyama America, Inc.
K896980	PALFIQUE LIGHT LINER	May 15, 1990	Substantially Equivalent	Tokuyama America, Inc.
K896139	SR-IVOSEAL	Apr 16, 1990	Substantially Equivalent	Ivoclar North America, Inc.
K896130	SR-IVOCAP	Apr 16, 1990	Substantially Equivalent	Ivoclar North America, Inc.
K896719	PRIMER-P ADHESIVE AGENT	Feb 22, 1990	Substantially Equivalent	Parkell
K895714	ORTHO-KEV APPLIANCE REINFORCING SYSTEM	Dec 21, 1989	Substantially Equivalent	American Orthodontics
K895742	LITELINE VLC SOFT RELINE	Dec 18, 1989	Substantially Equivalent	Dentsply Intl.
K895222	CURAY-FORM	Oct 24, 1989	Substantially Equivalent	Scientific Pharmaceuticals, Inc.
K894564	RELIANCE LIGHT CURE RETAINER ACRYLIC	Oct 17, 1989	Substantially Equivalent	Reliance Orthodontic Products, Inc.
K892452	PALASEAL(R)	Jun 16, 1989	Substantially Equivalent	Kulzer, Inc.
K890830	DENTURE RESIN	May 01, 1989	Substantially Equivalent	G-C Intl. Corp.
K884865	PERMASEAL AND DENTURE SEAL	Jan 30, 1989	Substantially Equivalent	American Mfg., Inc.
K884751	DANSU PERMANENT CHAIR SOFT LINER	Jan 27, 1989	Substantially Equivalent	American Mfg., Inc.
K883799	BASE, DENTURE, RELINING, REPAIRING, REBASING,RESIN	Oct 20, 1988	Substantially Equivalent	Austenal Dental, Inc.
K882482	TRIAD ORTHODONTIC GEL	Aug 12, 1988	Substantially Equivalent	Dentsply Intl.
K881245	DENT-URE LINER SOFT RESILIENT DENTURE LINING MATER	Jul 21, 1988	Substantially Equivalent	Cadco Dental Products, Inc.
K874025	2ND MODIFIED VINYLAC PRESS PACK DENTURE RESIN	Dec 23, 1987	Substantially Equivalent	Astron Dental Corp.
K873738	ACRYLIC BASE DENTURE MATERIALS	Nov 20, 1987	Substantially Equivalent	E&D Dental Manufacturing Co.
K871849	LIGHT CURE DENTURE GLAZE	Aug 10, 1987	Substantially Equivalent	Austenal Dental, Inc.
K871497	LINER OR GSRI-PNF	Jun 17, 1987	Substantially Equivalent	Gulf South Research Institute
K871038	LUTEMOLL (BIOPLAST)	May 19, 1987	Substantially Equivalent	B. L. Dental Co.
K871312	FIBREFLEX	Apr 15, 1987	Substantially Equivalent	Biomedical Composites, Ltd.
K870908	STEADY RESIN	Mar 19, 1987	Substantially Equivalent	Great Lakes Orthodontics, Ltd.
K863630	AUSTENAL ACUPAC 20 DENTURE BASE MATERIAL	Mar 11, 1987	Substantially Equivalent	Austenal Dental, Inc.
K864708	SR 3/60 NF DENTURE MATER. & SELF-CURE DENT. RESIN	Feb 25, 1987	Substantially Equivalent	Ivoclar USA, Inc.
K870148	DURA ORTHO ACRYLIC	Feb 19, 1987	Substantially Equivalent	Reliance Dental Mfg. Co.
K862557	AUSTENAL ACUSOFT SOFT LINER	Feb 19, 1987	Substantially Equivalent	Austenal Dental, Inc.
K864757	MODIFIED VINYLAC PRESS PACK DENTURE RESIN	Feb 10, 1987	Substantially Equivalent	Astron Dental Corp.
K864709	IVOCRYL HEAT CURE & IVOCRYL QUICK DENTURE MATERIAL	Feb 10, 1987	Substantially Equivalent	Ivoclar USA, Inc.
K863324	TRIAD IMPACT	Sep 05, 1986	Substantially Equivalent	Dentsply Intl.
K862558	AUSTENAL ACUPAC HI DENTURE BASE MATERIAL	Jul 18, 1986	Substantially Equivalent	Austenal Dental, Inc.
K861239	ACRYLIC SOLDER	Apr 17, 1986	Substantially Equivalent	Parker Laboratories, Inc.
K853094	EMPEROR 5/20 & STD, C.C, ORTHO, PSP REFIT, PERISEA	Apr 04, 1986	Substantially Equivalent	Psp Dental Co., Ltd.
K852741	DURA CONDITIONER	Sep 23, 1985	Substantially Equivalent	Reliance Dental Mfg. Co.
K850650	DENTAL ACRYLIC POLYMERS	May 22, 1985	Substantially Equivalent	Cole Polymers , Ltd.
K842477	CREDENT RADIOPAQUE DENTURE RESIN	Dec 03, 1984	Substantially Equivalent	Credent Co.
K842476	CREDENT RADIOPAQUE CROWN & BRIDE	Dec 03, 1984	Substantially Equivalent	Credent Co.
K842576	CLEAR LINER	Sep 27, 1984	Substantially Equivalent	Harry J. Bosworth Co.
K833270	ASTRON 77 INJECTION DENTURE RESIN	Jul 19, 1984	Substantially Equivalent	Astron Dental Corp.
K840405	BOSWORTH DENT-ALL	May 01, 1984	Substantially Equivalent	Harry J. Bosworth Co.
K840548	RESIL	Apr 17, 1984	Substantially Equivalent	Parker Laboratories, Inc.
K834409	DENTURE BASE RESIN	Feb 27, 1984	Substantially Equivalent	Dentsply Intl.
K834435	CROWN & BRIDGE RESIN	Feb 21, 1984	Substantially Equivalent	Rohm and Haas Co.
K831095	ROYALE II	Aug 31, 1983	Substantially Equivalent	Factor, Ii, Inc.
K831647	DENTURE RELINING, REPAIR/REBASING RESIN	Jun 30, 1983	Substantially Equivalent	Dentsply Intl.
K831269	VINYLAC PRESS-PACK DENTURE RESIN	Jun 08, 1983	Substantially Equivalent	Astron Dental Corp.
K823568	POLY-TONE DENTURE BASE RESIN	Jan 12, 1983	Substantially Equivalent	General Dental Products, Inc.
K821217	REIGNING DENTURE	Jun 07, 1982	Substantially Equivalent	Oki Shiks USA , Ltd.
K821230	SOFTIC 49	May 28, 1982	Substantially Equivalent	The Healthcare Group Laboratories, Inc.
K820673	SELF-CURING HARD DENTURE LINER	Apr 09, 1982	Substantially Equivalent	Coe Laboratories, Inc.
K810869	SILICONE ELASTOMER KIT	Apr 29, 1981	Substantially Equivalent	Rapid Injection Systems Corp.
K810687	SR-IVOCAP	Apr 14, 1981	Substantially Equivalent	J. Aderer, Inc.
K810094	DENTURE RUBBER BASE MATERIAL	Feb 02, 1981	Substantially Equivalent	Bosworth Co.
K802490	REIGNING DENTURE	Nov 19, 1980	Substantially Equivalent	Oki Shiks USA , Ltd.
K802491	REIGNING REPAIR EPOXY RESIN	Nov 12, 1980	Substantially Equivalent	Oki Shiks USA , Ltd.
K801234	REIGNING DENTURE MADE OF POLYCARB. RESIN	Jun 09, 1980	Substantially Equivalent	Oki Shiks USA , Ltd.
K800458	ORTHODONTICARTIDE	Mar 25, 1980	Substantially Equivalent	European Orthodontic Products
K800400	MAXUM DENTURE RESIN	Mar 12, 1980	Substantially Equivalent	Dentsply Intl.
K792427	PERMA-CRYL 20	Dec 13, 1979	Substantially Equivalent	Coe Laboratories, Inc.
K792042	DENTURE BASE RESIN	Nov 30, 1979	Substantially Equivalent	Dentsply Intl.
K790325	REPRODENT	Mar 02, 1979	Substantially Equivalent	Premier Dental Products Co.
K780786	DENTURE RELINE MATERIAL	Jun 14, 1978	Substantially Equivalent	Dentsply Intl.