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

FDA 510(k) Number Applicant Device Name Decision Date
K223365 Belport Company, Inc., Gingi-Pak RODIN Palette Naturalizing Kit 03/27/2023
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
K240735 Bredent GmbH & Co. KG visio.lign color, visio.lign shield 12/12/2024
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
K070306 DENTSPLY INTERNATIONAL, INC. PAINT- ON POLISH AGENT 03/22/2007
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
K133836 GC AMERICA INC. OPTIGLAZE COLOR 03/06/2014
K052462 GC AMERICA, INC. G-COAT 10/20/2005
K250804 ID KOREA CO., LTD. ID LIGHT CURE SYSTEM 06/04/2025
K123761 INNOVATION MEDITECH GMBH VITA ENAMIC STAINS 03/01/2013
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
K080549 PARKELL, INC. DURAFINISH ALL-CURE, MODEL S296 05/13/2008
K040599 PARKELL, INC. PARKELL RESIN GLAZE 04/09/2004
K073243 RELIANCE ORTHODONTIC PRODUCTS, INC. LED PRO SEAL 02/08/2008
K984037 ROYDENT DENTAL PRODUCTS, INC. CORE-IDE 02/04/1999
K163568 Shofu Dental Corporation SHOFU RESIN GLAZE 08/16/2017
K211854 VITA Zahnfabrik GmbH H Rauter & Co VITA Akzent LC 11/22/2021
K082285 VOCO GMBH EASY GLAZE 10/24/2008


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