Product Code: EBD FDA class 2 21 CFR 872.3310

Coating, Filling Material, Resin

Dental

The Resin Filling Material Coating is a dental material applied over a completed resin restoration to improve its surface finish, reduce microleakage, and seal surface imperfections, thereby improving durability and clinical performance of the restoration. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) clearance before marketing. The product code is EBD and the applicable regulation is 21 CFR 872.3310, under the Dental medical specialty. This device is eligible for third-party 510(k) review.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: EBD
Device Class: FDA class 2
Regulation Number: 872.3310
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 52 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K254091	GLOSSY COAT (15ML)	Apr 06, 2026	Substantially Equivalent	YAMAHACHI DENTAL MFG., Co.
K250804	ID LIGHT CURE SYSTEM	Jun 04, 2025	Substantially Equivalent	Id Korea Co., Ltd.
K240735	visio.lign color, visio.lign shield	Dec 12, 2024	Substantially Equivalent	Bredent GmbH & Co. KG
K223365	RODIN Palette Naturalizing Kit	Mar 27, 2023	Substantially Equivalent	Belport Company, Inc., Gingi-Pak
K211854	VITA Akzent LC	Nov 22, 2021	Substantially Equivalent	Vita Zahnfabrik GmbH H Rauter & CO
K162408	Nano Varnish, Plaquit, Lightpaint on Surface	Apr 05, 2018	Substantially Equivalent	Dreve Dentamid GmbH
K163568	SHOFU RESIN GLAZE	Aug 16, 2017	Substantially Equivalent	Shofu Dental Corporation
K133836	OPTIGLAZE COLOR	Mar 06, 2014	Substantially Equivalent	GC America, Inc.
K123761	VITA ENAMIC STAINS	Mar 01, 2013	Substantially Equivalent	Innovation Meditech GmbH
K093019	ENAMELITE ACRYSEAL SPRAY SEALANT	Dec 22, 2009	Substantially Equivalent	Enamelite, LLC
K082285	EASY GLAZE	Oct 24, 2008	Substantially Equivalent	Voco GmbH
K080549	DURAFINISH ALL-CURE, MODEL S296	May 13, 2008	Substantially Equivalent	Parkell, Inc.
K073243	LED PRO SEAL	Feb 08, 2008	Substantially Equivalent	Reliance Orthodontic Products, Inc.
K070306	PAINT- ON POLISH AGENT	Mar 22, 2007	Substantially Equivalent	Dentsply International, Inc.
K063228	SURFACE COAT	Dec 08, 2006	Substantially Equivalent	Kuraray America, Inc.
K052462	G-COAT	Oct 20, 2005	Substantially Equivalent	GC America, Inc.
K051999	BISCOVER LED	Aug 22, 2005	Substantially Equivalent	Bisco, Inc.
K043168	BISCOVER LV	Feb 01, 2005	Substantially Equivalent	Bisco, Inc.
K040599	PARKELL RESIN GLAZE	Apr 09, 2004	Substantially Equivalent	Parkell, Inc.
K030646	BELLEGLASS POINT 4	May 06, 2003	Substantially Equivalent	Kerr Dental Materials Center
K030585	SCULPTING RESIN	Apr 28, 2003	Substantially Equivalent	Bisco, Inc.
K030354	BISCOVER LIQUID POLISH KIT, BISCOVER LIQUID POLISH AND BISCOVER VISCOSITY MODIFIER	Feb 19, 2003	Substantially Equivalent	Bisco, Inc.
K024046	TESCERA GLAZING RESIN, MODEL T-1804, BISCOVER XT, MODEL G-93220P	Feb 06, 2003	Substantially Equivalent	Bisco, Inc.
K021503	UNINHIBITED	Aug 01, 2002	Substantially Equivalent	Bisco, Inc.
K011239	GINDA GUARD	Feb 14, 2002	Substantially Equivalent	Cosmedent, Inc.
K013179	LUXAGLAZE	Oct 12, 2001	Substantially Equivalent	Dmg USA, Inc.
K992067	BELLEGLAZE	Aug 27, 1999	Substantially Equivalent	Kerr Dental Materials Center
K984037	CORE-IDE	Feb 04, 1999	Substantially Equivalent	Roydent Dental Products, Inc.
K980298	FLOWABLE HYBRID	Mar 09, 1998	Substantially Equivalent	Cosmedent, Inc.
K974494	RENAMEL FLOWABLE COMPOSITE	Feb 10, 1998	Substantially Equivalent	Cosmedent, Inc.
K935689	IONOSIT BASE LINER	Jan 21, 1994	Substantially Equivalent	Foremost Dental Mfg., Co.
K904135	FOUNDATION HYBRID COMPOSITE	May 15, 1991	Substantially Equivalent	Nulite Systems Research
K901050	NO-STICK COMPOSITE INSTRUMENT DIP	Apr 19, 1990	Substantially Equivalent	Pulpdent Corp.
K862590	3M ESTHETIC DESIGN SYSTEM (TINTS & MASKING AGENTS)	Jul 22, 1986	Substantially Equivalent	3M Company
K854957	AUSTENAL DENTAL COMPOSITE RESIN	Jan 30, 1986	Substantially Equivalent	Austenal Dental, Inc.
K844845	ESPE KETAC-BOND	Aug 19, 1985	Substantially Equivalent	Espe GmbH (Us)
K850610	PEPSODENT DENTURE ADHESIVE CREAM	May 15, 1985	Substantially Equivalent	Lever Brothers Company, Inc.
K850675	CURAY JOIN DENT DENTIN PRIMER	Mar 25, 1985	Substantially Equivalent	Scientific Pharmaceuticals, Inc.
K850641	CAULK DYCAL LIGHT CURED	Mar 18, 1985	Substantially Equivalent	Dentsply Intl.
K850073	J & J LIGHT CURING DENTIN/ENAMEL BONDING AGENT	Feb 08, 1985	Substantially Equivalent	Johnson & Johnson Professionals, Inc.
K840751	OPAQUE COATING & SURFACE STAIN	May 11, 1984	Substantially Equivalent	Dentsply Intl.
K832834	CONCISE 2 SMALL PARTICLE LIGHT CURVED	Sep 29, 1983	Substantially Equivalent	3M Company
K823732	CBM, CORE BUILD-UP MATERIAL	Dec 28, 1982	Substantially Equivalent	Scientific Pharmaceuticals, Inc.
K822869	COMMAND BONDING RESIN/GLAZE/OPAQUER	Oct 13, 1982	Substantially Equivalent	Sybron Corp.
K822714	CONCLUDE COMPOSITE LUTING CEMENT	Sep 28, 1982	Substantially Equivalent	3M Company
K813328	MYERSON/KENSON GP POLYMER	Feb 24, 1982	Substantially Equivalent	Howmedica Corp.
K810813	DMG-POLISHABLE COMPOSITE	Apr 14, 1981	Substantially Equivalent	Dental-Material Gesellschaft
K791078	ANTERIOR/POSTERIOR RESTORATIVE, BOND	Aug 10, 1979	Substantially Equivalent	Scientific Pharmaceuticals, Inc.
K791067	SCI-PHARM PAINT-ON RESTORATIVE	Aug 10, 1979	Substantially Equivalent	Scientific Pharmaceuticals, Inc.
K790438	COLORANT	Apr 10, 1979	Substantially Equivalent	Vivadent (Usa), Inc.
K781345	ULTRAFILL- ULTRABOUND	Aug 31, 1978	Substantially Equivalent	Demetron Research Corp.
K760419	ADHESION PROMOTOR	Aug 23, 1976	Substantially Equivalent	Lee Pharmaceuticals