Atlas FDA

EBD

52 FDA 510(k) clearances · Product code

63 daysmedian time to decision
240 days90th percentile
52clearances measured

FDA profile

Official device name
Coating, Filling Material, Resin
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3310
Medical specialty
Dental
Flags
Third-party review eligible
Adverse events (MAUDE)
1994: 1 · 1998: 1 · 2008: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
GLOSSY COAT (15ML) (K254091)YAMAHACHI DENTAL MFG., Co.2026-04-06
ID LIGHT CURE SYSTEM (K250804)Id Korea Co., Ltd.2025-06-04
visio.lign color, visio.lign shield (K240735)Bredent GmbH & Co. KG2024-12-12
RODIN Palette Naturalizing Kit (K223365)Belport Company, Inc., Gingi-Pak2023-03-27
VITA Akzent LC (K211854)Vita Zahnfabrik GmbH H Rauter & CO2021-11-22
Nano Varnish, Plaquit, Lightpaint on Surface (K162408)Dreve Dentamid GmbH2018-04-05
SHOFU RESIN GLAZE (K163568)Shofu Dental Corporation2017-08-16
OPTIGLAZE COLOR (K133836)GC America, Inc.2014-03-06
VITA ENAMIC STAINS (K123761)Innovation Meditech GmbH2013-03-01
ENAMELITE ACRYSEAL SPRAY SEALANT (K093019)Enamelite, LLC2009-12-22
EASY GLAZE (K082285)Voco GmbH2008-10-24
DURAFINISH ALL-CURE, MODEL S296 (K080549)Parkell, Inc.2008-05-13
LED PRO SEAL (K073243)Reliance Orthodontic Products, Inc.2008-02-08
PAINT- ON POLISH AGENT (K070306)Dentsply International, Inc.2007-03-22
SURFACE COAT (K063228)Kuraray America, Inc.2006-12-08
G-COAT (K052462)GC America, Inc.2005-10-20
BISCOVER LED (K051999)Bisco, Inc.2005-08-22
BISCOVER LV (K043168)Bisco, Inc.2005-02-01
PARKELL RESIN GLAZE (K040599)Parkell, Inc.2004-04-09
BELLEGLASS POINT 4 (K030646)Kerr Dental Materials Center2003-05-06
SCULPTING RESIN (K030585)Bisco, Inc.2003-04-28
BISCOVER LIQUID POLISH KIT, BISCOVER LIQUID POLISH AND BISCOVER VISCOSITY MODIFIER (K030354)Bisco, Inc.2003-02-19
TESCERA GLAZING RESIN, MODEL T-1804, BISCOVER XT, MODEL G-93220P (K024046)Bisco, Inc.2003-02-06
UNINHIBITED (K021503)Bisco, Inc.2002-08-01
GINDA GUARD (K011239)Cosmedent, Inc.2002-02-14
LUXAGLAZE (K013179)Dmg USA, Inc.2001-10-12
BELLEGLAZE (K992067)Kerr Dental Materials Center1999-08-27
CORE-IDE (K984037)Roydent Dental Products, Inc.1999-02-04
FLOWABLE HYBRID (K980298)Cosmedent, Inc.1998-03-09
RENAMEL FLOWABLE COMPOSITE (K974494)Cosmedent, Inc.1998-02-10
IONOSIT BASE LINER (K935689)Foremost Dental Mfg., Co.1994-01-21
FOUNDATION HYBRID COMPOSITE (K904135)Nulite Systems Research1991-05-15
NO-STICK COMPOSITE INSTRUMENT DIP (K901050)Pulpdent Corp.1990-04-19
3M ESTHETIC DESIGN SYSTEM (TINTS & MASKING AGENTS) (K862590)3M Company1986-07-22
AUSTENAL DENTAL COMPOSITE RESIN (K854957)Austenal Dental, Inc.1986-01-30
ESPE KETAC-BOND (K844845)Espe GmbH (Us)1985-08-19
PEPSODENT DENTURE ADHESIVE CREAM (K850610)Lever Brothers Company, Inc.1985-05-15
CURAY JOIN DENT DENTIN PRIMER (K850675)Scientific Pharmaceuticals, Inc.1985-03-25
CAULK DYCAL LIGHT CURED (K850641)Dentsply Intl.1985-03-18
J & J LIGHT CURING DENTIN/ENAMEL BONDING AGENT (K850073)Johnson & Johnson Professionals, Inc.1985-02-08
OPAQUE COATING & SURFACE STAIN (K840751)Dentsply Intl.1984-05-11
CONCISE 2 SMALL PARTICLE LIGHT CURVED (K832834)3M Company1983-09-29
CBM, CORE BUILD-UP MATERIAL (K823732)Scientific Pharmaceuticals, Inc.1982-12-28
COMMAND BONDING RESIN/GLAZE/OPAQUER (K822869)Sybron Corp.1982-10-13
CONCLUDE COMPOSITE LUTING CEMENT (K822714)3M Company1982-09-28
MYERSON/KENSON GP POLYMER (K813328)Howmedica Corp.1982-02-24
DMG-POLISHABLE COMPOSITE (K810813)Dental-Material Gesellschaft1981-04-14
ANTERIOR/POSTERIOR RESTORATIVE, BOND (K791078)Scientific Pharmaceuticals, Inc.1979-08-10
SCI-PHARM PAINT-ON RESTORATIVE (K791067)Scientific Pharmaceuticals, Inc.1979-08-10
COLORANT (K790438)Vivadent (Usa), Inc.1979-04-10
ULTRAFILL- ULTRABOUND (K781345)Demetron Research Corp.1978-08-31
ADHESION PROMOTOR (K760419)Lee Pharmaceuticals1976-08-23

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