Atlas FDA

EJR

77 FDA 510(k) clearances · Product code

82 daysmedian time to decision
196 days90th percentile
77clearances measured

FDA profile

Official device name
Agent, Polishing, Abrasive, Oral Cavity
Device class
Class I (low risk)
Regulation
21 CFR 872.6030
Medical specialty
Dental
Adverse events (MAUDE)
2006: 4 · 2007: 6 · 2010: 3 · 2013: 9 · 2015: 10 · 2016: 9
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
AIR-FLOW PLUS Prophylaxis powder (K171189)E.M.S Electro Medical Systems S.A2017-09-11
WHIP MIX PREPPIES PLUS (K131760)Whip-Mix Corp.2014-03-26
NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMIN (K121698)Dentsply International, Inc.2012-08-06
OSSPRAY SYLC CR (K103114)Osspray, Ltd.2011-03-14
BUTLER CALCI-FLOR PROPHYLAXIS PASTE (K102053)Sunstar Americas, Inc.2011-02-03
REMIN PRO (K101104)Voco GmbH2010-10-21
PREVENTECH PROPHYLAXIS PASTE WITH FLUORIDE (K100539)Preventive Technologies, Inc.2010-06-17
GC MI PASTE PLUS (K070854)GC America, Inc.2007-04-12
OSSPRAY CLEANING COMPOUND (K062502)Ospray, Ltd.2006-12-15
ENAMEL PRO (K062166)Premier Dental Products Co.2006-11-21
GELATO PROPHYLAXIS PASTE (K042048)Deepak Products, Inc.2004-10-26
MI PASTE (K042200)GC America, Inc.2004-10-20
BUTLER NUCARE PROPHYLAXIS PASTE WITH NOVAMIN (K041371)Novamin Technology, Inc.2004-08-23
ZIRCON-F PROPHYLAXIS PASTE (K040988)Pascal Co., Inc.2004-07-07
PROACTIVE CARE PROPHYLAXIS PASTE WITH FLUORIDE (K033785)Discus Dental, Inc.2004-06-18
RADENT PROPHY PASTE (K040661)Pascal Co., Inc.2004-06-09
PRO-DENTEC DOUBLE-PRO PROPHYLAXIS PASTE WITH FLUOIDE FAMILY OF DEVICES (K033449)Professional Dental Technologies Therapeutics, Inc.2004-01-07
BUTLER GUM PROPHY PASTE WITH NOVAMIN (K024343)Usbiomaterials Corp.2003-07-11
PROCLUDE (K002989)Ortek Therapeutics, Inc.2000-12-14
NUPRO PROPHYLAXIS PASTE WITH FLUORIDE AND TRICLOSAN (K000169)Dentsply Intl.2000-03-24
3M CLINPRO PROPHY PASTE, MODEL 12611 (K990482)Minnesota Mining and Mfg. Co.1999-05-13
RE NU (K973289)Pacific Rim Dental, Inc.1999-02-09
NUPRO PROPHYLAXIS PASTE WITH FLOURIDE AND TRICLOSAN (K983966)Dentsply Intl.1999-01-29
PERFECT CHOICE PROPHY PASTE WITH 10% CARBAMIDE PEROXIDE (K962370)Challenge Products, Inc.1997-03-31
AQUAFRESH PLAQUE FIGHTING GUM (K944575)Smithkline Beecham Consumer Healthcare Products1994-12-15
SMILE INTEGRATED PROPHYLAXIS PASTE RINGS (K942851)Germiphene Corp.1994-11-04
PROPHY PASTE (K940496)Challenge Products, Inc.1994-04-19
VISION PROPHY PASTE WITH FLUORIDE (K935925)Block Drug Company, Inc.1994-01-26
VISION PROPHY PASTE WITHOUT FLUORIDE (K933893)Block Drug Company, Inc.1993-11-16
DENSPRO MEDIUM MINT PROPHY PASTE (K923675)Teledyne Getz1992-11-05
DENSPRO COARSE MINT PROPHY PASTE (K923674)Teledyne Getz1992-11-05
CLEANIC (K923020)Hawe Neos Dental1992-09-09
SATIN PROPHYLAXIS PASTE (K912945)Dentsply Intl.1991-09-16
ABUTMENT GLO (K905303)Implant Innovations International, Inc.1991-06-10
PULPDENT DIAMOND POLISH (K911284)Pulpdent Corp.1991-05-30
SWIRL PROPHYLAXIS PASTE (K903986)Bio-Medica Concepts1991-03-28
HORIZON REGULAR ETCHING GEL (K904199)Horizon Chemical Co.1990-12-05
PROPHY PASTE (K901580)Dentsply Intl.1990-09-06
MPS DIAMOND POLISHING GEL (K903003)Abrasive Technology, Inc.1990-08-29
ULTRA II PORCELAIN POLISHING PASTE (K896071)Shofu Dental Corp.1990-08-14
DEGUFILL (R) POLISHING GEL (K901873)Degussa AG1990-08-13
CP-3 DENTAL POLISHING MATERIAL (K901973)Gresco Products, Inc.1990-06-01
PULPDENT OIL FREE SURFACE PREPARATION PASTE (K901052)Pulpdent Corp.1990-04-16
KEN'S PROPHY GEL - REGULAR (K896661)Pulpdent Corp.1990-02-14
PERLIDENT (K894933)Germiphene Corp.1989-10-12
ENAMEL MICROABRASION COMPOUND (K891536)Premier Dental Products Co.1989-06-09
JETPOLISHER AIRPOLISHING POWDER (K875339)Young Dental Manufacturing Co. 1, LLC1988-04-18
DIAMOND-LUSTER DENTAL POLISHING PASTE (K873686)Scientific Pharmaceuticals, Inc.1987-11-12
ABRASIVE DISC - POLISHING WHEEL (K872251)Dentsply Intl.1987-07-02
JOHNSON & JOHNSON STAINING REMOVING COMPOUND (K864226)Johnson & Johnson Professionals, Inc.1987-05-01
PROPHY CARE SOLUTION (K865082)Imd, Inc.1987-02-12
PROPHY CARE SOLUTION (K864215)Imd, Inc.1986-11-18
PROPHY CARE PASTE (K863133)Imd, Inc.1986-09-25
RENAMELIZE POLISHING PASTE (K862912)Cosmedent, Inc.1986-08-12
CHECK-UP PLAQUE FIGHTING GUM (K860843)Minnetonka, Inc.1986-05-21
SCI-PRO, PROPHYLAXIS PASTE (K854828)Scientific Pharmaceuticals, Inc.1986-03-26
DENSCO PROPHY PASTE (K854829)Scientific Pharmaceuticals, Inc.1986-03-25
INSTA-GLAZE (K854588)George Taub Products & Fusion Co., Inc.1986-02-04
CUPRIDENT (K851073)Bio Systems, Inc.1985-07-31
GLOSSY POLISHING PASTE (K852814)Scientific Pharmaceuticals, Inc.1985-07-31
TEMREX DENTAL POLISHING PASTE (K852157)Scientific Pharmaceuticals, Inc.1985-07-19
PROPOL DENTAL POLISHING PASTE (K852489)Scientific Pharmaceuticals, Inc.1985-07-01
KERR COMMAND ULTRAFINE POLISHING PASTE (K843022)Kerr Corporation (Danbury)1984-08-24
LUSTER, DENTAL POLISHING PASTE (K842403)Scientific Pharmaceuticals, Inc.1984-08-17
DIAMOND LUSTRE (K840254)Jelrus Technical Products Corp.1984-04-25
DIABRITE (K822894)Antraco, Inc.1982-10-18
DIAGLAZE (K822142)Antraco, Inc.1982-09-14
NIMETIC POLISHING PASTE (K812118)Espe-Premier Sales Co.1981-08-31
ALLOY COMPOSITE POLISH (K810912)Moyco Industries, Inc.1981-04-23
DENTAL CHEWING GUM (SUGARLESS) (K810037)Mcdennan Oral Products, Inc.1981-04-08
DEN-MAT POLISHING PASTE (K801225)Den-Mat Corp.1980-06-17
MIRADAPT* POLISHING INSTRUMENTS (K791319)Johnson & Johnson Professionals, Inc.1979-09-12
PREVI DENT PROPHYLAXIS MINT NDC (K780834)Hoyt Laboratories1978-06-02
NIMETIC POLISHING PASTE (K771852)Espe GmbH (Us)1977-11-02
PROPHY PASTE (K771401)L.D. Caulk Co.1977-08-22
DETARTRINE P (K760658)Septodont, Inc.1976-09-27
DETARTRINE Z (K760656)Mr. J. Garrick Eisenberg1976-09-27

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Every clearance here is in the API, with alerts when new ones post.