Agent, Polishing, Abrasive, Oral Cavity
Regulation 872.6030
0510(k)s in 12 months (77 all time)
0recalls in 12 months (1 all time)
0recalls that name a 510(k)
Top companies in EJR
| Company | 510(k)s | Recalls |
|---|---|---|
| Scientific Pharmaceuticals, Inc. | 7 | 0 |
| Dentsply Intl. | 5 | 0 |
| Imd, Inc. | 3 | 0 |
| Pulpdent Corp. | 3 | 0 |
| Antraco, Inc. | 2 | 0 |
| Block Drug Company, Inc. | 2 | 0 |
| Challenge Products, Inc. | 2 | 0 |
| GC America, Inc. | 2 | 0 |
| Germiphene Corp. | 2 | 0 |
| Johnson & Johnson Professionals, Inc. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 11, 2017 | K171189 | AIR-FLOW PLUS Prophylaxis powder E.M.S Electro Medical Systems S.A, CH | EJR |
| Mar 26, 2014 | K131760 | WHIP MIX PREPPIES PLUS Whip-Mix Corp. | EJR |
| Aug 6, 2012 | K121698 | NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMIN Dentsply International, Inc. | EJR |
| Mar 14, 2011 | K103114 | OSSPRAY SYLC CR Osspray, Ltd., GB | EJR |
| Feb 3, 2011 | K102053 | BUTLER CALCI-FLOR PROPHYLAXIS PASTE Sunstar Americas, Inc. | EJR |
| Oct 21, 2010 | K101104 | REMIN PRO Voco GmbH, DE | EJR |
| Jun 17, 2010 | K100539 | PREVENTECH PROPHYLAXIS PASTE WITH FLUORIDE Preventive Technologies, Inc. | EJR |
| Apr 12, 2007 | K070854 | GC MI PASTE PLUS GC America, Inc. | EJR |
| Dec 15, 2006 | K062502 | OSSPRAY CLEANING COMPOUND Ospray, Ltd. | EJR |
| Nov 21, 2006 | K062166 | ENAMEL PRO Premier Dental Products Co. | EJR |
| Oct 26, 2004 | K042048 | GELATO PROPHYLAXIS PASTE Deepak Products, Inc. | EJR |
| Oct 20, 2004 | K042200 | MI PASTE GC America, Inc. | EJR |
| Aug 23, 2004 | K041371 | BUTLER NUCARE PROPHYLAXIS PASTE WITH NOVAMIN Novamin Technology, Inc. | EJR |
| Jul 7, 2004 | K040988 | ZIRCON-F PROPHYLAXIS PASTE Pascal Co., Inc. | EJR |
| Jun 18, 2004 | K033785 | PROACTIVE CARE PROPHYLAXIS PASTE WITH FLUORIDE Discus Dental, Inc. | EJR |
| Jun 9, 2004 | K040661 | RADENT PROPHY PASTE Pascal Co., Inc. | EJR |
| Jan 7, 2004 | K033449 | PRO-DENTEC DOUBLE-PRO PROPHYLAXIS PASTE WITH FLUOIDE FAMILY OF DEVICES Professional Dental Technologies Therapeutics, Inc. | EJR |
| Jul 11, 2003 | K024343 | BUTLER GUM PROPHY PASTE WITH NOVAMIN Usbiomaterials Corp. | EJR |
| Dec 14, 2000 | K002989 | PROCLUDE Ortek Therapeutics, Inc. | EJR |
| Mar 24, 2000 | K000169 | NUPRO PROPHYLAXIS PASTE WITH FLUORIDE AND TRICLOSAN Dentsply Intl. | EJR |
| May 13, 1999 | K990482 | 3M CLINPRO PROPHY PASTE, MODEL 12611 Minnesota Mining and Mfg. Co. | EJR |
| Feb 9, 1999 | K973289 | RE NU Pacific Rim Dental, Inc. | EJR |
| Jan 29, 1999 | K983966 | NUPRO PROPHYLAXIS PASTE WITH FLOURIDE AND TRICLOSAN Dentsply Intl. | EJR |
| Mar 31, 1997 | K962370 | PERFECT CHOICE PROPHY PASTE WITH 10% CARBAMIDE PEROXIDE Challenge Products, Inc. | EJR |
| Dec 15, 1994 | K944575 | AQUAFRESH PLAQUE FIGHTING GUM Smithkline Beecham Consumer Healthcare Products | EJR |
| Nov 4, 1994 | K942851 | SMILE INTEGRATED PROPHYLAXIS PASTE RINGS Germiphene Corp., CA | EJR |
| Apr 19, 1994 | K940496 | PROPHY PASTE Challenge Products, Inc. | EJR |
| Jan 26, 1994 | K935925 | VISION PROPHY PASTE WITH FLUORIDE Block Drug Company, Inc. | EJR |
| Nov 16, 1993 | K933893 | VISION PROPHY PASTE WITHOUT FLUORIDE Block Drug Company, Inc. | EJR |
| Nov 5, 1992 | K923675 | DENSPRO MEDIUM MINT PROPHY PASTE Teledyne Getz | EJR |
| Nov 5, 1992 | K923674 | DENSPRO COARSE MINT PROPHY PASTE Teledyne Getz | EJR |
| Sep 9, 1992 | K923020 | CLEANIC Hawe Neos Dental, CH | EJR |
| Sep 16, 1991 | K912945 | SATIN PROPHYLAXIS PASTE Dentsply Intl. | EJR |
| Jun 10, 1991 | K905303 | ABUTMENT GLO Implant Innovations International, Inc. | EJR |
| May 30, 1991 | K911284 | PULPDENT DIAMOND POLISH Pulpdent Corp. | EJR |
| Mar 28, 1991 | K903986 | SWIRL PROPHYLAXIS PASTE Bio-Medica Concepts | EJR |
| Dec 5, 1990 | K904199 | HORIZON REGULAR ETCHING GEL Horizon Chemical Co. | EJR |
| Sep 6, 1990 | K901580 | PROPHY PASTE Dentsply Intl. | EJR |
| Aug 29, 1990 | K903003 | MPS DIAMOND POLISHING GEL Abrasive Technology, Inc. | EJR |
| Aug 14, 1990 | K896071 | ULTRA II PORCELAIN POLISHING PASTE Shofu Dental Corp. | EJR |
| Aug 13, 1990 | K901873 | DEGUFILL (R) POLISHING GEL Degussa AG, DE | EJR |
| Jun 1, 1990 | K901973 | CP-3 DENTAL POLISHING MATERIAL Gresco Products, Inc. | EJR |
| Apr 16, 1990 | K901052 | PULPDENT OIL FREE SURFACE PREPARATION PASTE Pulpdent Corp. | EJR |
| Feb 14, 1990 | K896661 | KEN'S PROPHY GEL - REGULAR Pulpdent Corp. | EJR |
| Oct 12, 1989 | K894933 | PERLIDENT Germiphene Corp., CA | EJR |
| Jun 9, 1989 | K891536 | ENAMEL MICROABRASION COMPOUND Premier Dental Products Co. | EJR |
| Apr 18, 1988 | K875339 | JETPOLISHER AIRPOLISHING POWDER Young Dental Manufacturing Co. 1, LLC | EJR |
| Nov 12, 1987 | K873686 | DIAMOND-LUSTER DENTAL POLISHING PASTE Scientific Pharmaceuticals, Inc. | EJR |
| Jul 2, 1987 | K872251 | ABRASIVE DISC - POLISHING WHEEL Dentsply Intl. | EJR |
| May 1, 1987 | K864226 | JOHNSON & JOHNSON STAINING REMOVING COMPOUND Johnson & Johnson Professionals, Inc. | EJR |
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