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 |
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 |
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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