FDA 510(k) Applications for Medical Device Product Code "EBD"
(Coating, Filling Material, Resin)

FDA 510(k) Number Applicant Device Name Decision Date
K862590 3M COMPANY 3M ESTHETIC DESIGN SYSTEM (TINTS & MASKING AGENTS) 07/22/1986
K832834 3M COMPANY CONCISE 2 SMALL PARTICLE LIGHT CURVED 09/29/1983
K822714 3M COMPANY CONCLUDE COMPOSITE LUTING CEMENT 09/28/1982
K854957 AUSTENAL DENTAL, INC. AUSTENAL DENTAL COMPOSITE RESIN 01/30/1986
K051999 BISCO, INC. BISCOVER LED 08/22/2005
K030354 BISCO, INC. BISCOVER LIQUID POLISH KIT, BISCOVER LIQUID POLISH AND BISCOVER VISCOSITY MODIFIER 02/19/2003
K043168 BISCO, INC. BISCOVER LV 02/01/2005
K030585 BISCO, INC. SCULPTING RESIN 04/28/2003
K024046 BISCO, INC. TESCERA GLAZING RESIN, MODEL T-1804, BISCOVER XT, MODEL G-93220P 02/06/2003
K021503 BISCO, INC. UNINHIBITED 08/01/2002
K980298 COSMEDENT, INC. FLOWABLE HYBRID 03/09/1998
K011239 COSMEDENT, INC. GINDA GUARD 02/14/2002
K974494 COSMEDENT, INC. RENAMEL FLOWABLE COMPOSITE 02/10/1998
K781345 DEMETRON RESEARCH CORP. ULTRAFILL- ULTRABOUND 08/31/1978
K810813 DENTAL-MATERIAL GESELLSCHAFT DMG-POLISHABLE COMPOSITE 04/14/1981
K070306 DENTSPLY INTERNATIONAL, INC. PAINT- ON POLISH AGENT 03/22/2007
K850641 DENTSPLY INTL. CAULK DYCAL LIGHT CURED 03/18/1985
K840751 DENTSPLY INTL. OPAQUE COATING & SURFACE STAIN 05/11/1984
K013179 DMG USA, INC. LUXAGLAZE 10/12/2001
K162408 DREVE DENTAMID GMBH Nano Varnish, Plaquit, Lightpaint on Surface 04/05/2018
K093019 ENAMELITE LLC ENAMELITE ACRYSEAL SPRAY SEALANT 12/22/2009
K844845 ESPE GMBH (US) ESPE KETAC-BOND 08/19/1985
K935689 FOREMOST DENTAL MFG., CO. IONOSIT BASE LINER 01/21/1994
K133836 GC AMERICA INC. OPTIGLAZE COLOR 03/06/2014
K052462 GC AMERICA, INC. G-COAT 10/20/2005
K813328 HOWMEDICA CORP. MYERSON/KENSON GP POLYMER 02/24/1982
K123761 INNOVATION MEDITECH GMBH VITA ENAMIC STAINS 03/01/2013
K850073 JOHNSON & JOHNSON PROFESSIONALS, INC. J & J LIGHT CURING DENTIN/ENAMEL BONDING AGENT 02/08/1985
K030646 KERR DENTAL MATERIALS CENTER BELLEGLASS POINT 4 05/06/2003
K992067 KERR DENTAL MATERIALS CENTER BELLEGLAZE 08/27/1999
K063228 KURARAY AMERICA, INC. SURFACE COAT 12/08/2006
K760419 LEE PHARMACEUTICALS ADHESION PROMOTOR 08/23/1976
K850610 LEVER BROTHERS COMPANY, INC. PEPSODENT DENTURE ADHESIVE CREAM 05/15/1985
K904135 NULITE SYSTEMS RESEARCH FOUNDATION HYBRID COMPOSITE 05/15/1991
K080549 PARKELL, INC. DURAFINISH ALL-CURE, MODEL S296 05/13/2008
K040599 PARKELL, INC. PARKELL RESIN GLAZE 04/09/2004
K901050 PULPDENT CORP. NO-STICK COMPOSITE INSTRUMENT DIP 04/19/1990
K073243 RELIANCE ORTHODONTIC PRODUCTS, INC. LED PRO SEAL 02/08/2008
K984037 ROYDENT DENTAL PRODUCTS, INC. CORE-IDE 02/04/1999
K791078 SCIENTIFIC PHARMACEUTICALS, INC. ANTERIOR/POSTERIOR RESTORATIVE, BOND 08/10/1979
K823732 SCIENTIFIC PHARMACEUTICALS, INC. CBM, CORE BUILD-UP MATERIAL 12/28/1982
K850675 SCIENTIFIC PHARMACEUTICALS, INC. CURAY JOIN DENT DENTIN PRIMER 03/25/1985
K791067 SCIENTIFIC PHARMACEUTICALS, INC. SCI-PHARM PAINT-ON RESTORATIVE 08/10/1979
K163568 Shofu Dental Corporation SHOFU RESIN GLAZE 08/16/2017
K822869 SYBRON CORP. COMMAND BONDING RESIN/GLAZE/OPAQUER 10/13/1982
K790438 VIVADENT (USA), INC. COLORANT 04/10/1979
K082285 VOCO GMBH EASY GLAZE 10/24/2008


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