Dental Device Guide
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Prosthetic devices · 21 CFR 872 Subpart D

Resin Filling Material Coating

FDA device type “Coating, Filling Material, Resin”.

FDA codeEBDClass221 CFR872.3310Pathway510(k)
Companies listing it
3423 makers
Brands and models
66
510(k) clearances
525 in five years
FDA name
Coating, Filling Material, Resin
1976: 11978: 11979: 31981: 11982: 41983: 11984: 11985: 51986: 21990: 11991: 11994: 11998: 21999: 22001: 12002: 22003: 42004: 12005: 32006: 12007: 12008: 32009: 12013: 12014: 12017: 12018: 12021: 12023: 12024: 12025: 12026: 119801990200020102020

510(k) clearances per year, 1976–2026

Companies that list EBD

34 companies currently list this device type with FDA.

CompanyCountryRoleBrands and models listedClearancesLatest
Dentsply Sirona, Inc.United StatesMakerLucitone Digital Print for Primeprint1482026
Voco GmbHGermanyMakerEasy Glaze1172026
Shofu IncJapanMakerSHOFU RESIN GLAZE962025
GC America Inc.United StatesMakerFoundation · G-COAT · G-Coat Plus · GC Optiglaze · +31372026
Kulzer, LLCUnited StatesMakerSignum composite · Signum composite flow · Signum cre-active · Signum liquid · +3372026
Ivoclar Vivadent, AGUnited StatesMakerIPS Empress Direct Effect942026
Deltamed GmbHGermanyMakerRenamel® Flowable Microfill62024
Bisco, Inc.United StatesMakerMODELING RESIN882025
Parkell, IncUnited StatesMaker—582025
Den-Mat Holdings, LLCUnited StatesMakerVirtuoso Sealant · Visar Seal82026
Vita Zahnfabrik H. Rauter GmbH & Co. Kg.GermanyMakerAkzent LC · VITA ENAMIC Stains82026
Pac-Dent Inc.United StatesMaker—52022
Yamahachi Dental Mfg. Co.JapanMakerGLOSSY COAT32026
Dreve Dentamid GmbHGermanyMakerNanoVarnish · Plaquit62025
DMG Chemisch-Pharmazeutische Fabrik GmbHGermanyMakerIonosit Baseliner 10x 0.3g USA · Ionosit Baseliner 2x 1.5g USA · Ionosit Microspand 10x 0,3g · Ionosit Microspand 1x 0,3g · +442022
bredent GmbH & Co. KGGermanyMakervisio.lign color · visio.lign shield32024
Id Korea Co., Ltd.South KoreaMakerID Light Cure System12025
Pulpdent CorporationUnited StatesMakerEmbrace WetBond First-Coat · Embrace WetBond Seal-n-Shine · Ortho-Choice Ortho-Coat1072021
Scientific PharmaceuticalsUnited StatesMakerCBM (Core Build-Up Material) · CuRAY Dentin/Enamel Bonding System · SciPharm Anterior/Posterior Composite Restorative, Paste/Paste Type with Bonding Agent732020
Reliance Orthodontic Products, Inc.United StatesMakerLED Proseal · Pro Seal322021
George Taub Products & Fusion Co., Inc.United StatesMakerDenture Base Staining Kit · Glaze Kit · L. M. D. Elixirs · Larry's Magical Denture Elixirs · +121986
Solventum US LLCUnited StatesMaker———
Leixir Resources Private LimitedIndiaMakerLucitone Digital Print Denture System——
Cosmedent, Inc.United StatesRepacker / relabelerGingaGuard · Renamel Flowable Microfill · Renamel Flowable Microhybrid272024
Five Star Orthodontic Laboratory & Supply, Inc.United StatesContract manufacturerPro Seal——
Jersey Dental SuppliesUnited StatesRepacker / relabelerCAULK DYCAL LIGHT CURED——
TitanLinks Logistics LLCUnited StatesRepacker / relabelercoating · Filling material——
Soher Med LimitedHong Kong SAR ChinaForeign exporterFilling material · Pit & Fissure——
Samtrade Supplies Inc.CanadaForeign exporterDycal Ivory——
Dentonics IncUnited StatesRepacker / relabelerMaster-Dent——
indigodental GmbHGermanyForeign exporterQuikGlaze · QuikGlaze Temp White · QuikGlaze XL——
Mainline Medical Dental SupplyCanadaForeign exporter———
Oketz Logistics LLCUnited StatesRepacker / relabeler———
Worldwide Supplies LimitedHong Kong SAR ChinaForeign exporter———

510(k) clearances

Decided510(k)DeviceApplicant
6 Apr 2026K254091GLOSSY COAT (15ML)Yamahachi Dental Mfg. Co.
4 Jun 2025K250804ID LIGHT CURE SYSTEMId Korea Co., Ltd.
12 Dec 2024K240735visio.lign color, visio.lign shieldbredent GmbH & Co. KG
27 Mar 2023K223365RODIN Palette Naturalizing KitBelport Company, Inc., Gingi-Pak
22 Nov 2021K211854VITA Akzent LCVita Zahnfabrik GmbH H Rauter & CO
5 Apr 2018K162408Nano Varnish, Plaquit, Lightpaint on SurfaceDreve Dentamid GmbH
16 Aug 2017K163568SHOFU RESIN GLAZEShofu Inc
6 Mar 2014K133836OPTIGLAZE COLORGC America Inc.
1 Mar 2013K123761VITA ENAMIC STAINSInnovation Meditech GmbH
22 Dec 2009K093019ENAMELITE ACRYSEAL SPRAY SEALANTEnamelite, LLC
24 Oct 2008K082285EASY GLAZEVoco GmbH
13 May 2008K080549DURAFINISH ALL-CURE, MODEL S296Parkell, Inc
8 Feb 2008K073243LED PRO SEALReliance Orthodontic Products, Inc.
22 Mar 2007K070306PAINT- ON POLISH AGENTDentsply International, Inc.
8 Dec 2006K063228SURFACE COATKuraray America, Inc.
20 Oct 2005K052462G-COATGC America Inc.
22 Aug 2005K051999BISCOVER LEDBisco, Inc.
1 Feb 2005K043168BISCOVER LVBisco, Inc.
9 Apr 2004K040599PARKELL RESIN GLAZEParkell, Inc
6 May 2003K030646BELLEGLASS POINT 4Kerr Dental Materials Center
28 Apr 2003K030585SCULPTING RESINBisco, Inc.
19 Feb 2003K030354BISCOVER LIQUID POLISH KIT, BISCOVER LIQUID POLISH AND BISCOVER VISCOSITY MODIFIERBisco, Inc.
6 Feb 2003K024046TESCERA GLAZING RESIN, MODEL T-1804, BISCOVER XT, MODEL G-93220PBisco, Inc.
1 Aug 2002K021503UNINHIBITEDBisco, Inc.
14 Feb 2002K011239GINDA GUARDCosmedent, Inc.
12 Oct 2001K013179LUXAGLAZEDmg USA, Inc.
27 Aug 1999K992067BELLEGLAZEKerr Dental Materials Center
4 Feb 1999K984037CORE-IDERoydent Dental Products, Inc.
9 Mar 1998K980298FLOWABLE HYBRIDCosmedent, Inc.
10 Feb 1998K974494RENAMEL FLOWABLE COMPOSITECosmedent, Inc.
21 Jan 1994K935689IONOSIT BASE LINERForemost Dental Mfg., Inc.
15 May 1991K904135FOUNDATION HYBRID COMPOSITENulite Systems Research
19 Apr 1990K901050NO-STICK COMPOSITE INSTRUMENT DIPPulpdent Corporation
22 Jul 1986K8625903M ESTHETIC DESIGN SYSTEM (TINTS & MASKING AGENTS)3M Company
30 Jan 1986K854957AUSTENAL DENTAL COMPOSITE RESINAustenal Dental, Inc.
19 Aug 1985K844845ESPE KETAC-BONDEspe GmbH (Us)
15 May 1985K850610PEPSODENT DENTURE ADHESIVE CREAMLever Brothers Company, Inc.
25 Mar 1985K850675CURAY JOIN DENT DENTIN PRIMERScientific Pharmaceuticals
18 Mar 1985K850641CAULK DYCAL LIGHT CUREDDentsply Intl., Inc.
8 Feb 1985K850073J & J LIGHT CURING DENTIN/ENAMEL BONDING AGENTJohnson & Johnson Professionals, Inc.
11 May 1984K840751OPAQUE COATING & SURFACE STAINDentsply Intl., Inc.
29 Sep 1983K832834CONCISE 2 SMALL PARTICLE LIGHT CURVED3M Company
28 Dec 1982K823732CBM, CORE BUILD-UP MATERIALScientific Pharmaceuticals
13 Oct 1982K822869COMMAND BONDING RESIN/GLAZE/OPAQUERSybron Corp.
28 Sep 1982K822714CONCLUDE COMPOSITE LUTING CEMENT3M Company
24 Feb 1982K813328MYERSON/KENSON GP POLYMERHowmedica Corp.
14 Apr 1981K810813DMG-POLISHABLE COMPOSITEDental-Material Gesellschaft
10 Aug 1979K791078ANTERIOR/POSTERIOR RESTORATIVE, BONDScientific Pharmaceuticals
10 Aug 1979K791067SCI-PHARM PAINT-ON RESTORATIVEScientific Pharmaceuticals
10 Apr 1979K790438COLORANTVivadent (Usa), Inc.
31 Aug 1978K781345ULTRAFILL- ULTRABOUNDDemetron Research Corp.
23 Aug 1976K760419ADHESION PROMOTORLee Pharmaceuticals

Official records: FDA product classification for EBD · 21 CFR 872.3310.

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026