Product Code: EBZ FDA class 2 21 CFR 872.6070

Activator, Ultraviolet, For Polymerization

Dental

The Ultraviolet Activator for Polymerization is a dental device that emits ultraviolet light to initiate and accelerate the curing (hardening) of UV-sensitive dental resins, sealants, and adhesives used in restorative procedures. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) clearance before marketing. The product code is EBZ and the applicable regulation is 21 CFR 872.6070, under the Dental medical specialty. This device is eligible for third-party 510(k) review.

View on FDA

510(k)s

214

FEI Numbers

101

Registration Numbers

101

Unique Applicants

126

Years Active

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Basic Information

Product Code: EBZ
Device Class: FDA class 2
Regulation Number: 872.6070
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 214 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K253131	Curing Light (M-Cure 6)	Jun 18, 2026	Substantially Equivalent	Guangzhou Rebornendo Medical Instrument Co., Ltd.
K253461	Demi Pro	Oct 14, 2025	Substantially Equivalent	Meta Systems Co., Ltd.
K242386	Bluemoon	May 05, 2025	Substantially Equivalent	Genoss Co., Ltd.
K243921	LED Curing Lights (DB686 HALO)	Apr 11, 2025	Substantially Equivalent	Foshan Coxo Medical Instrument Co., Ltd.
K250009	LED Curing Light (C01-X, C02-X)	Apr 10, 2025	Substantially Equivalent	Premium Plus (Dongguan) Limited
K241238	LOOP LED Curing Light System (CLK01)	Aug 01, 2024	Substantially Equivalent	Garrison Dental Solutions, LLC
K223414	Curing Light, Model: MaxCure 9	Nov 15, 2023	Substantially Equivalent	Guilin Refine Medical Instrument Co., Ltd.
K233518	BASE290 LED Curing Light	Nov 02, 2023	Substantially Equivalent	Handpiece Headquarters
K223507	CL-DP40 (Drs Light PRIME), CL-DP40 (Drs Light CHOICE)	Aug 04, 2023	Substantially Equivalent	Good Doctors Co., Ltd.
K223142	Coltolux Comfort LED Curing Light	Dec 22, 2022	Substantially Equivalent	Dent4you AG
K220826	LED Curing Light	Dec 08, 2022	Substantially Equivalent	Foshan Coxo Medical Instrument Co., Ltd.
K221152	CuringPen Dental Curing Light	Nov 23, 2022	Substantially Equivalent	Changzhou Sifary Medical Technology Co., Ltd.
K221194	LEDEX	Sep 16, 2022	Substantially Equivalent	Dentmate Technology Co. , Ltd.
K220471	VALO X, VALO X Accessory Lenses	Feb 22, 2022	Substantially Equivalent	Ultradent Products, Inc.
K210550	VALO Grand Corded and Accessory Lenses	Mar 01, 2021	Substantially Equivalent	Ultradent Products, Inc.
K200775	LOOP LED Curing Light System	Aug 14, 2020	Substantially Equivalent	Garrison Dental Solutions, LLC
K200809	D-LUX+	Aug 07, 2020	Substantially Equivalent	DiaDent Group International
K192233	LED Curing Light	Feb 13, 2020	Substantially Equivalent	Foshan Cicada Dental Instrument Co, Ltd.
K191221	Cybird LED Curing Light	Jan 10, 2020	Substantially Equivalent	Dxm Co., Ltd.
K192009	LED Curing Light	Jan 09, 2020	Substantially Equivalent	Ezgo Group, Inc.
K191865	SmartLite Pro Modular LED Curing Light	Nov 20, 2019	Substantially Equivalent	Dentsply Sirona
K190272	Bluephase PowerCure	Jul 03, 2019	Substantially Equivalent	Ivoclar Vivadent, AG
K190627	VALO Grand Corded	Apr 29, 2019	Substantially Equivalent	Ultradent Products, Inc.
K180065	FUSION Plus Curing Light	Apr 19, 2019	Substantially Equivalent	Dentlight, Inc.
K181597	Le'Pen	Apr 01, 2019	Substantially Equivalent	Kmihh, Ltd.
K173157	Dr's Light2	May 29, 2018	Substantially Equivalent	Good Doctors Co., Ltd.
K173876	Cybird LED Curing Light	Jan 24, 2018	Substantially Equivalent	Dxm Co., Ltd.
K161855	LED Curing Light	Nov 27, 2017	Substantially Equivalent	Monitex Industrial Co., Ltd.
K172426	Clear Blue Digi LED Curing Light	Aug 16, 2017	Substantially Equivalent	Promident, LLC
K170529	Delight, Delight ortho, B&Lite S	Aug 08, 2017	Substantially Equivalent	Dentall Co., Ltd.
K163064	Demi Ultra	Jul 18, 2017	Substantially Equivalent	Kerr Corporation
K170101	Valiant Curing Light	Jun 08, 2017	Substantially Equivalent	Inter-Med/Vista Dental Products
K152192	LED Curing Light	Apr 07, 2017	Substantially Equivalent	Monitex Industrial Co., Ltd.
K163613	Bluephase Style 20i	Apr 04, 2017	Substantially Equivalent	Ivoclar Vivadent, AG
K163605	LEDEX WL070+	Jan 19, 2017	Substantially Equivalent	Dentmate Technology Co. , Ltd.
K153514	Premium Plus C01/C02 LED Curing Light	Aug 22, 2016	Substantially Equivalent	Premium Plus International Limited
K160551	VALO Grand	Jul 13, 2016	Substantially Equivalent	Ultradent Products, Inc.
K153078	LED Curing Light GT-2000	Jun 28, 2016	Substantially Equivalent	Monitex Industrial Co., Ltd.
K153018	CELALUX 3	Jun 23, 2016	Substantially Equivalent	Voco GmbH
K150585	Ascent 3D	Dec 31, 2015	Substantially Equivalent	CAO Group, Inc.
K152936	Sirius Max Dental Diode Curing Light	Nov 13, 2015	Substantially Equivalent	National Dental, Inc.
K150205	LED Curing Light	Aug 24, 2015	Substantially Equivalent	Monitex Industrial Co., Ltd.
K140432	HI-LIGHT, HI-LIGHT PLUS	Aug 03, 2015	Substantially Equivalent	Dentall Corporation
K133040	LED CURING LIGHT	Oct 07, 2014	Substantially Equivalent	Monitex Industrial Co., Ltd.
K140281	FLEXI-LUME LED SYSTEM	Jul 24, 2014	Substantially Equivalent	Epic Medical Concepts & Innovations
K131906	SCANWAVE PEN (WITH LIGHT GRAY CORD), SCANWAVE PEN (WITH MEDIUM GRAY CORD), SCANWAVE PEN (WITH DARK GRAY CORD), SCANWAVE	Apr 11, 2014	Substantially Equivalent	Satelec - Acteon Group
K131042	LEDEX	Oct 03, 2013	Substantially Equivalent	Dentmate Technology Co. , Ltd.
K130163	D-LUX	Aug 16, 2013	Substantially Equivalent	DiaDent Group International
K123468	DEMI ULTRA	Mar 20, 2013	Substantially Equivalent	Kerr Corporation
K121093	D1 LED CURING LIGHT, SPEC 3, DENTRONIX LED 3000	Nov 27, 2012	Substantially Equivalent	Dxm Co., Ltd.
K110756	BLUEPHASE STYLE	Aug 29, 2011	Substantially Equivalent	Ivoclar Vivadent, Inc.
K110582	VALO CORDLESS	Apr 28, 2011	Substantially Equivalent	Ultradent Products, Inc.
K102621	SOLSTICE	Jan 28, 2011	Substantially Equivalent	Kerr Corporation
K093751	CL-DC20, CL-DC21	Feb 24, 2010	Substantially Equivalent	Good Doctors Co., Ltd.
K092951	STARLIGHT PRO AND SILIVERLIGHT DENTAL CURING LIGHTS	Dec 07, 2009	Substantially Equivalent	Mectron S.P.A.
K091887	LED CURING LIGHT, MODEL GT-1500	Sep 18, 2009	Substantially Equivalent	Monitex Industrial Co., Ltd.
K091020	BLUEPHASE 20I	Jun 12, 2009	Substantially Equivalent	Ivoclar Vivadent, Inc.
K083647	VALO, MODEL 5919	Jan 23, 2009	Substantially Equivalent	Ultradent Products, Inc.
K082408	LEDEX, MODEL: WL-070	Dec 03, 2008	Substantially Equivalent	Dentmate Technology Co. , Ltd.
K081287	SAPPHIRE PLASMA ARC DENTAL CURING LIGHT	Nov 21, 2008	Substantially Equivalent	Den-Mat Holdings, LLC
K082971	BONART ART-L5 LED CORDLESS CURING LIGHT	Nov 13, 2008	Substantially Equivalent	Bonart Co., Ltd.
K080025	LED.L, LED.M, LED.G, LED.B	Mar 19, 2008	Substantially Equivalent	Guilin Woodpecker Medical Instrument Co., Ltd.
K080035	LED CURING LIGHT	Mar 03, 2008	Substantially Equivalent	Monitex Industrial Co., Ltd.
K073518	FLASHLITE REBEL*	Dec 20, 2007	Substantially Equivalent	Discus Dental, Inc.
K072807	I LIGHT	Nov 21, 2007	Substantially Equivalent	Dent'N CO
K072181	MINI LED AUTOFOCUS	Sep 19, 2007	Substantially Equivalent	Satelec
K071908	DOCTOR'S LIGHT LED DENTAL CURING LIGHT	Aug 23, 2007	Substantially Equivalent	Good Doctors Co., Ltd.
K071722	DEEP BLUE	Aug 10, 2007	Substantially Equivalent	E.M.S Electro Medical Systems S.A
K071251	DEMI	Jul 26, 2007	Substantially Equivalent	Kerr Corporation
K063659	EASY CURING PEN-STYLE LED CURING LIGHT	Apr 30, 2007	Substantially Equivalent	Dent Corp. Research & Development
K070373	APOZA LED CURING LIGHT, MODEL E-MORLIT, D-2000, TOP 3W, TOP 5W	Mar 02, 2007	Substantially Equivalent	Apoza Enterprise Co., Ltd.
K063529	PENCURE, MODEL VL-7	Jan 05, 2007	Substantially Equivalent	J. Morita USA, Inc.
K062289	BONART ART-L3 LED CURING LIGHT	Jan 03, 2007	Substantially Equivalent	Bonart Co., Ltd.
K063116	DEMETRON A.2	Dec 05, 2006	Substantially Equivalent	Sybron Dental Specialties
K063003	AURORA	Nov 28, 2006	Substantially Equivalent	Parkell, Inc.
K062735	TUTU 7, MODEL IV-T22	Oct 27, 2006	Substantially Equivalent	Invisible Technology Co., Ltd.
K061658	SPIRIT, MODEL M, U; DOCPORTMACRO, MODEL M, U, L	Sep 18, 2006	Substantially Equivalent	Dentall Corp.
K061695	LED PROLUX 770	Sep 14, 2006	Substantially Equivalent	Peng Lim Enterprise Co., Ltd.
K061395	CALSET COMPOSITE HEATER	Jun 23, 2006	Substantially Equivalent	Addent, Inc.
K061341	PALMLIGHT 10, MODEL 001-00030	Jun 12, 2006	Substantially Equivalent	CAO Group, Inc.
K060646	BLUE LUXCER CURING LIGHT, MODELS M-830, M-835 AND M-855	Apr 21, 2006	Substantially Equivalent	Monitex Industrial Co., Ltd.
K052122	BISCO LED	Mar 29, 2006	Substantially Equivalent	Bisco, Inc.
K052349	AVANTE LED CURING UNIT, MODEL N44	Oct 21, 2005	Substantially Equivalent	Pentron Clinical Technologies
K052593	FUSION CURING LIGHT	Sep 28, 2005	Substantially Equivalent	Dentlight, Inc.
K051782	BLUEPHASE 16I	Sep 20, 2005	Substantially Equivalent	Ivoclar Vivadent, Inc.
K051780	JETLITE 5000	Jul 28, 2005	Substantially Equivalent	J. Morita USA, Inc.
K051571	SKYLIGHT LED CURING LIGHT	Jul 19, 2005	Substantially Equivalent	Dmetec.Co., Ltd.
K051545	L.E. DEMETRON II	Jul 18, 2005	Substantially Equivalent	Kerr Corporation (Danbury)
K051203	BLUELEX	May 25, 2005	Substantially Equivalent	Monitex Industrial Co., Ltd.
K050059	G-LIGHT	Feb 03, 2005	Substantially Equivalent	GC America, Inc.
K043530	DVI CURING LIGHT	Jan 25, 2005	Substantially Equivalent	Designs For Vision, Inc.
K043302	NOVA-PULSE	Jan 03, 2005	Substantially Equivalent	Nova Ranger, Inc.
K042888	DEMETRON IDS CURING LIGHT	Nov 10, 2004	Substantially Equivalent	Kerr Corp.
K042196	SAVEDENT BLUE	Nov 01, 2004	Substantially Equivalent	Denfotex Light Systems, Ltd.
K042703	CYBIRD LED CURING LIGHT	Oct 12, 2004	Substantially Equivalent	Dxm Co., Ltd.
K042199	TRANSLUX POWER BLUE	Sep 08, 2004	Substantially Equivalent	Heraeus Kulzer,GmbH
K041372	SMARTLITE PS PEN-STYLE LED CURING LIGHT	Jun 24, 2004	Substantially Equivalent	Dentsply International
K041303	LED TURBO-PEN	Jun 18, 2004	Substantially Equivalent	Apoza Enterprise Co., Ltd.
K040956	HILUX LEDMAX 3	Jun 14, 2004	Substantially Equivalent	First Medical Infection Control Associates, Inc.
K040808	MINI L.E.D. OEM MODULE	Apr 28, 2004	Substantially Equivalent	Satelec
K040614	BLUEWAND LED DENTAL CURING WAND SYSTEM	Apr 07, 2004	Substantially Equivalent	J.L. Blosser, Inc.
K040618	LED TURBO	Mar 25, 2004	Substantially Equivalent	Apoza Enterprise Co., Ltd.
K040551	COLTOLUX LED CURING LIGHT	Mar 15, 2004	Substantially Equivalent	Coltene/Whaledent, Inc.
K033697	POWER LED	Feb 27, 2004	Substantially Equivalent	Dental Products of USA, Inc.
K033795	PLASMACURE BXE	Dec 19, 2003	Substantially Equivalent	Eele Laboratories, LLC
K033520	BLUEPHASE	Dec 05, 2003	Substantially Equivalent	Ivoclar Vivadent, Inc.
K033201	LA500 BLUE LIGHT	Dec 02, 2003	Substantially Equivalent	Apoza Enterprise Co., Ltd.
K032099	SWISS MASTER LIGHT	Oct 27, 2003	Substantially Equivalent	(Ems Sa) Electro Medical Systems
K032465	MINI L.E.D., MODEL: MINI L.E.D., MODEL SMARTLITE MINI	Oct 21, 2003	Substantially Equivalent	Satelec
K031615	SLED CURING LIGHT SYSTEM	Jul 21, 2003	Substantially Equivalent	Dentsply International
K030811	COOL CURE	Jun 10, 2003	Substantially Equivalent	Samm, Inc.
K030641	CONTEC LIGHT	Jun 10, 2003	Substantially Equivalent	Dentaurum
K030568	RADII	Apr 24, 2003	Substantially Equivalent	Southern Dental Industries, Inc.
K024374	RMO PLASMA CURING LIGHT	Mar 10, 2003	Substantially Equivalent	Lokki Lasers Medicaux
K023748	FLASH-LITE II LED DENTAL CURING LIGHT	Jan 17, 2003	Substantially Equivalent	Discus Dental, Inc.
K023721	BONART ART-L2 LIGHT CURING UNIT	Jan 10, 2003	Substantially Equivalent	Bonart Co., Ltd.
K023652	REMECURE MODEL CL 15E	Jan 09, 2003	Substantially Equivalent	Remedent NV
K023545	ULTRA-LITE 200E LIGHT CURE UNIT	Dec 30, 2002	Substantially Equivalent	Rolence Ent., Inc.
K022862	TRANSCURE, MODEL 2910	Oct 18, 2002	Substantially Equivalent	Kinetic Instruments, Inc.
K022265	LIGHT TIP	Oct 02, 2002	Substantially Equivalent	Svenska Dental Instruments AB
K020057	PALMLIGHT	Aug 27, 2002	Substantially Equivalent	CAO Group, Inc.
K022184	FLASH-LITE LED DENTAL CURING LIGHT	Aug 20, 2002	Substantially Equivalent	Discus Dental, Inc.
K021797	L.E.DEMETRON	Jun 27, 2002	Substantially Equivalent	Sybron Dental Specialties, Inc.
K020884	EXCELLITE LIGHT CURE UNIT	Jun 12, 2002	Substantially Equivalent	Rolence Ent., Inc.
K020877	EXCELLITE TURBO LIGHT CURE UNIT	Jun 12, 2002	Substantially Equivalent	Rolence Ent., Inc.
K020874	ULTRA-LITE 5 TURBO LIGHT CURE UNIT	Jun 12, 2002	Substantially Equivalent	Rolence Ent., Inc.
K021374	TOESCO AQUA BLUE LED LIGHT CURING DEVICE	May 30, 2002	Substantially Equivalent	Toei Electric Co., Ltd.
K020267	OPTILUX CURING LIGHTS	Mar 29, 2002	Substantially Equivalent	Sybron Dental Specialties, Inc.
K020091	OPTILUX 501	Mar 21, 2002	Substantially Equivalent	Kerr Corporation (Danbury)
K014179	DEMETRON LC	Feb 04, 2002	Substantially Equivalent	Kerr Corp.
K020171	COOLBLU2 DENTAL RESIN CURING DEVICE	Jan 29, 2002	Substantially Equivalent	Dental Systems.Com, Inc.
K013500	KAVO POLYLUX II	Jan 14, 2002	Substantially Equivalent	Kavo America
K013277	ASTRALIS 7, MODEL 557545	Oct 22, 2001	Substantially Equivalent	Ivoclar Vivadent, Inc.
K013275	ASTRALIS 10, MODELS # 559588, 561859	Oct 19, 2001	Substantially Equivalent	Ivoclar Vivadent, Inc.
K012946	SUNLITELED MODEL #2810	Oct 02, 2001	Substantially Equivalent	Kinetic Instruments, Inc.
K012341	TRANSLUX ENERGY	Aug 30, 2001	Substantially Equivalent	Heraeus Kulzer, Inc.
K012134	GC E-LIGHT	Aug 07, 2001	Substantially Equivalent	GC America, Inc.
K011154	ELIPAR FREELIGHT	May 16, 2001	Substantially Equivalent	Espe Dental AG
K010133	VERSALUX	Apr 05, 2001	Substantially Equivalent	Centrix, Inc.
K003383	PALMLIGHT	Feb 06, 2001	Substantially Equivalent	Ultradent Products, Inc.
K003683	AVANTE CURELIGHT	Jan 11, 2001	Substantially Equivalent	Jeneric/Pentron, Inc.
K002925	COOLBLU CURING LIGHT	Dec 20, 2000	Substantially Equivalent	Dental Systems.Com, Inc.
K002991	ZAP DUAL CURING LIGHT	Nov 28, 2000	Substantially Equivalent	Soft-Core Texas, Inc.
K002566	LUMALITE CURE LIGHT, MODEL 2100	Oct 19, 2000	Substantially Equivalent	Lumalite, Inc.
K001719	Q-LUX PLASMA 100 LIGHT CURE UNIT	Oct 10, 2000	Substantially Equivalent	Rolence Enterprise Co. , Ltd.
K000078	JETLITE 4000	May 15, 2000	Substantially Equivalent	J. Morita USA, Inc.
K000426	VIP- VARIABLE INTENSITY POLYMERIZER	Apr 12, 2000	Substantially Equivalent	Bisco, Inc.
K000393	NOVA CORDLESS CURING LIGHT	Mar 27, 2000	Substantially Equivalent	Nova/Da Vinci Systems, Inc.
K994048	PORTABLE LIGHT CURING UNIT	Jan 13, 2000	Substantially Equivalent	Gregory S. Jacob, D.D.S.
K994028	FLIPO XENON CURING LIGHT	Jan 12, 2000	Substantially Equivalent	Lokki
K993223	RAPICURE 200 (CURING AND WHITENING LIGHT)	Nov 01, 1999	Substantially Equivalent	Mediphotonix, LC
K992728	SPRING POWERLITE 2000	Sep 29, 1999	Substantially Equivalent	Spring Health Products, Inc.
K992357	EASY-CURE (CURING AND WHITENING LIGHT)	Aug 30, 1999	Substantially Equivalent	Ics of North America, Inc.
K992236	LYSTA LC COMPACTA CURING LIGHT, MODELS LC 2500 COMPACTA, LC 4000 COMPACTA, LC 6000 COMPACTA & LC 8000 COMPATCA	Aug 27, 1999	Substantially Equivalent	Lysta A/S
K991865	Q-LITE 75 LIGHT CURE UNIT	Jul 20, 1999	Substantially Equivalent	Rolence Enterprise Co. , Ltd.
K991863	CUTE-LITE I LIGHT CURE UNIT	Jul 19, 1999	Substantially Equivalent	Rolence Enterprise Co. , Ltd.
K991138	LYSTA LC CURING LIGHT, MODEL LC 2500C/BA	Apr 23, 1999	Substantially Equivalent	Lysta A/S
K984247	ELIPAR TRILIGHT	Feb 25, 1999	Substantially Equivalent	Espe Dental AG
K982615	AIRDENT RADIANCE CURING LIGHT	Aug 24, 1998	Substantially Equivalent	Air Techniques, Inc.
K974369	APOLLO 9500	Jan 06, 1998	Substantially Equivalent	Ion Laser Technology
K972355	3M AURORA SYSTEM	Aug 29, 1997	Substantially Equivalent	3M Company
K972006	ACTA OEM MODULE	Jul 10, 1997	Substantially Equivalent	Interactive Consulting, Inc.
K970506	HILUX 200,250,275,300,350,500 DENTAL CURING LIGHT	Jun 04, 1997	Substantially Equivalent	Benlioglu Dental Ithalat, Inc.
K964524	ILT ARGON HP	Mar 18, 1997	Substantially Equivalent	Ion Laser Technology
K963110	JETLITE	Oct 24, 1996	Substantially Equivalent	J. Morita USA, Inc.
K961735	ACTA	Jul 31, 1996	Substantially Equivalent	Satelec
K960364	CU-200 LIGHT CURE UNIT	Apr 15, 1996	Substantially Equivalent	Rolence Enterprise Co. , Ltd.
K960351	Q-LUX LIGHT CURE UNIT	Apr 15, 1996	Substantially Equivalent	Rolence Enterprise Co. , Ltd.
K953898	ACL-5500 PRECISION CURING UNIT (PCU)	Feb 15, 1996	Substantially Equivalent	Ion Laser Technology
K955763	OPTILUX 400	Jan 04, 1996	Substantially Equivalent	Demetron Research Corp.
K955759	LITEX 680	Jan 02, 1996	Substantially Equivalent	Dentamerica
K954061	POLY-LITE MODEL 1000	Sep 21, 1995	Substantially Equivalent	Pro-Den Systems, Inc.
K952423	CU-100RLC LIGHT CURE UNIT, DOCUMENT NO.A715676	Jun 22, 1995	Substantially Equivalent	Rolence Enterprise Co. , Ltd.
K951465	SUNLITE 1275	May 31, 1995	Substantially Equivalent	Fen Dental Mfg., Inc.
K950106	COLTOLUX LIGHT METER	May 24, 1995	Substantially Equivalent	Coltene/Whaledent, Inc.
K945698	COLTOLUX 3, COLTOLUX 4	May 24, 1995	Substantially Equivalent	Coltene/Whaledent, Inc.
K951425	SPECTRUM CURING LIGHT POLYMERIZATION UNIT	May 05, 1995	Substantially Equivalent	Dentsply Intl.
K942199	CU-100R LIGHT CURE UNIT, DOCUMENT NO. A715676	Jun 02, 1994	Substantially Equivalent	Rolence Enterprise Co. , Ltd.
K942198	CU-80 LIGHT CURE UNIT, DOCUMENT NO. A715676	May 27, 1994	Substantially Equivalent	Rolence Enterprise Co. , Ltd.
K934746	3M CURING LIGHT XL1500	Jan 06, 1994	Substantially Equivalent	3M Company
K930086	ORTHOLUX XT	Apr 23, 1993	Substantially Equivalent	3M Company
K924812	3M CURING LIGHT XL 3000	Nov 25, 1992	Substantially Equivalent	3M Company
K912994	COMPALUX STROBOSCOPIC LIGHT POLYMERIZATION DEVICE	Dec 23, 1991	Substantially Equivalent	Wilde-USA, Inc.
K913980	HELIOLUX	Dec 16, 1991	Substantially Equivalent	Ivoclar North America, Inc.
K910068	SPECTRAMAT	Mar 15, 1991	Substantially Equivalent	Ivoclar North America, Inc.
K905543	LARES APOLLO CS/CP/C	Mar 11, 1991	Substantially Equivalent	Lares Research, Inc.
K901908	HELIOLUX VISIBLE CURING LIGHT	Jul 13, 1990	Substantially Equivalent	Ivoclar North America, Inc.
K900135	CU-75 VISIBLE LIGHT-CURING UNIT	May 07, 1990	Substantially Equivalent	Kab Gloves Unltd.
K895085	WALKLITE PROTABLE RE-CHARGEABLE CURING LIGHT	Apr 02, 1990	Substantially Equivalent	Lustgarten Multi-Tech International, Inc.
K892517	TULUX-FILTER	Aug 21, 1989	Substantially Equivalent	Espe GmbH (Us)
K892456	KULZER TRANSLUX EC	Jun 14, 1989	Substantially Equivalent	Kulzer, Inc.
K884222	CURING LIGHT COVER	Mar 17, 1989	Substantially Equivalent	Steri-Shield Products, Inc.
K882145	PHOTO-CURING LIGHT	Sep 06, 1988	Substantially Equivalent	Dentsply Intl.
K880392	ORTHOLUX VISIBLE LIGHT CURING UNIT	Apr 07, 1988	Substantially Equivalent	Unitek Corp.
K854696	OP II VISIBLE LIGHT CURING SYSTEM	Mar 26, 1986	Substantially Equivalent	Almore Intl., Inc.
K851915	CURING LIGHT	Jul 09, 1985	Substantially Equivalent	Technology, Inc.
K844351	OPTI-LITE	Dec 21, 1984	Substantially Equivalent	Innovators, Inc.
K844325	COE-LITE POLYMERIZATION UNIT	Dec 11, 1984	Substantially Equivalent	Coe Laboratories, Inc.
K843823	TRANSLUX CL	Dec 04, 1984	Substantially Equivalent	Kulzer, Inc.
K832320	PRISMA III	Aug 31, 1983	Substantially Equivalent	Dentsply Intl.
K822654	CURING LIGHT	Oct 04, 1982	Substantially Equivalent	Venture Technology, Inc.
K822642	OPTILUX & VISILUX DENTAL PHOTO LAMP	Sep 14, 1982	Substantially Equivalent	Demetron Research Corp.
K820693	MIDWEST LIGHT WAND	Apr 09, 1982	Substantially Equivalent	American Midwest
K811668	KULZER TRANSLUX VISIBLE LIGHT CURING	Jul 28, 1981	Substantially Equivalent	Kulzer, Inc.
K803209	ELIPAR LIGHT SOURCE	Jan 14, 1981	Substantially Equivalent	Espe-Premier Sales Co.
K801588	CAULK PRISMA-LITE	Sep 16, 1980	Substantially Equivalent	Dentsply Intl.
K780898	INSTANT CURE-1	Jun 30, 1978	Substantially Equivalent	Ultra-Light Corp.
K780518	ULTRANOVAR, DENTAL U.V. CURING LAMP	Apr 28, 1978	Substantially Equivalent	Demetron Research Corp.
K772278	FOTOFILL ACTIVATOR LIGHT	Jan 03, 1978	Substantially Equivalent	Johnson & Johnson Professionals, Inc.
K771889	UNIOLITE	Oct 20, 1977	Substantially Equivalent	Espe Dental Products
K771077	ULTRAVIOLET RAD-EMITTING LAMP	Jun 24, 1977	Substantially Equivalent	Lee Pharmaceuticals
K770215	ACTIVATOR LIGHT	Apr 15, 1977	Substantially Equivalent	Gte Sylvania, Inc.
K770599	NUVA-LITE II PHOTO-CURE UNIT	Apr 05, 1977	Substantially Equivalent	Dentsply Intl.
K770113	ESTILUX UV SYSTEM	Jan 28, 1977	Substantially Equivalent	Degussa Dental, Inc.