FDA Product Code
FDA Product Code EJR — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Dental
- 21 CFR Citation
- 872.6030
510(k) Clearances — 77 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K171189 | AIR-FLOW PLUS Prophylaxis powder | E.M.S Electro Medical Systems S.A | 2017-09-11 | Traditional | PDF ↗ |
| K131760 | WHIP MIX PREPPIES PLUS | Whip-Mix Corp. | 2014-03-26 | Traditional | PDF ↗ |
| K121698 | NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMIN | Dentsply International, Inc. | 2012-08-06 | Traditional | PDF ↗ |
| K103114 | OSSPRAY SYLC CR | Osspray, Ltd. | 2011-03-14 | Traditional | PDF ↗ |
| K102053 | BUTLER CALCI-FLOR PROPHYLAXIS PASTE | Sunstar Americas, Inc. | 2011-02-03 | Traditional | PDF ↗ |
| K101104 | REMIN PRO | Voco GmbH | 2010-10-21 | Traditional | PDF ↗ |
| K100539 | PREVENTECH PROPHYLAXIS PASTE WITH FLUORIDE | Preventive Technologies, Inc. | 2010-06-17 | Traditional | PDF ↗ |
| K070854 | GC MI PASTE PLUS | GC America, Inc. | 2007-04-12 | Special | PDF ↗ |
| K062502 | OSSPRAY CLEANING COMPOUND | Ospray, Ltd. | 2006-12-15 | Traditional | PDF ↗ |
| K062166 | ENAMEL PRO | Premier Dental Products Co. | 2006-11-21 | Traditional | PDF ↗ |
| K042048 | GELATO PROPHYLAXIS PASTE | Deepak Products, Inc. | 2004-10-26 | Traditional | PDF ↗ |
| K042200 | MI PASTE | GC America, Inc. | 2004-10-20 | Traditional | PDF ↗ |
| K041371 | BUTLER NUCARE PROPHYLAXIS PASTE WITH NOVAMIN | Novamin Technology, Inc. | 2004-08-23 | Traditional | PDF ↗ |
| K040988 | ZIRCON-F PROPHYLAXIS PASTE | Pascal Co., Inc. | 2004-07-07 | Traditional | PDF ↗ |
| K033785 | PROACTIVE CARE PROPHYLAXIS PASTE WITH FLUORIDE | Discus Dental, Inc. | 2004-06-18 | Traditional | PDF ↗ |
| K040661 | RADENT PROPHY PASTE | Pascal Co., Inc. | 2004-06-09 | Traditional | PDF ↗ |
| K033449 | PRO-DENTEC DOUBLE-PRO PROPHYLAXIS PASTE WITH FLUOIDE FAMILY OF DEVICES | Professional Dental Technologies Therapeutics, Inc. | 2004-01-07 | Traditional | PDF ↗ |
| K024343 | BUTLER GUM PROPHY PASTE WITH NOVAMIN | Usbiomaterials Corp. | 2003-07-11 | Traditional | PDF ↗ |
| K002989 | PROCLUDE | Ortek Therapeutics, Inc. | 2000-12-14 | Traditional | PDF ↗ |
| K000169 | NUPRO PROPHYLAXIS PASTE WITH FLUORIDE AND TRICLOSAN | Dentsply Intl. | 2000-03-24 | Traditional | PDF ↗ |
| K990482 | 3M CLINPRO PROPHY PASTE, MODEL 12611 | Minnesota Mining and Mfg. Co. | 1999-05-13 | Traditional | PDF ↗ |
| K973289 | RE NU | Pacific Rim Dental, Inc. | 1999-02-09 | Traditional | PDF ↗ |
| K983966 | NUPRO PROPHYLAXIS PASTE WITH FLOURIDE AND TRICLOSAN | Dentsply Intl. | 1999-01-29 | Traditional | PDF ↗ |
| K962370 | PERFECT CHOICE PROPHY PASTE WITH 10% CARBAMIDE PEROXIDE | Challenge Products, Inc. | 1997-03-31 | Traditional | PDF ↗ |
| K944575 | AQUAFRESH PLAQUE FIGHTING GUM | Smithkline Beecham Consumer Healthcare Products | 1994-12-15 | Traditional | PDF ↗ |
| K942851 | SMILE INTEGRATED PROPHYLAXIS PASTE RINGS | Germiphene Corp. | 1994-11-04 | Traditional | PDF ↗ |
| K940496 | PROPHY PASTE | Challenge Products, Inc. | 1994-04-19 | Traditional | PDF ↗ |
| K935925 | VISION PROPHY PASTE WITH FLUORIDE | Block Drug Company, Inc. | 1994-01-26 | Traditional | PDF ↗ |
| K933893 | VISION PROPHY PASTE WITHOUT FLUORIDE | Block Drug Company, Inc. | 1993-11-16 | Traditional | PDF ↗ |
| K923674 | DENSPRO COARSE MINT PROPHY PASTE | Teledyne Getz | 1992-11-05 | Traditional | PDF ↗ |
| K923675 | DENSPRO MEDIUM MINT PROPHY PASTE | Teledyne Getz | 1992-11-05 | Traditional | PDF ↗ |
| K923020 | CLEANIC | Hawe Neos Dental | 1992-09-09 | Traditional | PDF ↗ |
| K912945 | SATIN PROPHYLAXIS PASTE | Dentsply Intl. | 1991-09-16 | Traditional | PDF ↗ |
| K905303 | ABUTMENT GLO | Implant Innovations International, Inc. | 1991-06-10 | Traditional | PDF ↗ |
| K911284 | PULPDENT DIAMOND POLISH | Pulpdent Corp. | 1991-05-30 | Traditional | PDF ↗ |
| K903986 | SWIRL PROPHYLAXIS PASTE | Bio-Medica Concepts | 1991-03-28 | Traditional | PDF ↗ |
| K904199 | HORIZON REGULAR ETCHING GEL | Horizon Chemical Co. | 1990-12-05 | Traditional | PDF ↗ |
| K901580 | PROPHY PASTE | Dentsply Intl. | 1990-09-06 | Traditional | PDF ↗ |
| K903003 | MPS DIAMOND POLISHING GEL | Abrasive Technology, Inc. | 1990-08-29 | Traditional | PDF ↗ |
| K896071 | ULTRA II PORCELAIN POLISHING PASTE | Shofu Dental Corp. | 1990-08-14 | Traditional | PDF ↗ |
| K901873 | DEGUFILL (R) POLISHING GEL | Degussa AG | 1990-08-13 | Traditional | PDF ↗ |
| K901973 | CP-3 DENTAL POLISHING MATERIAL | Gresco Products, Inc. | 1990-06-01 | Traditional | PDF ↗ |
| K901052 | PULPDENT OIL FREE SURFACE PREPARATION PASTE | Pulpdent Corp. | 1990-04-16 | Traditional | PDF ↗ |
| K896661 | KEN'S PROPHY GEL - REGULAR | Pulpdent Corp. | 1990-02-14 | Traditional | PDF ↗ |
| K894933 | PERLIDENT | Germiphene Corp. | 1989-10-12 | Traditional | PDF ↗ |
| K891536 | ENAMEL MICROABRASION COMPOUND | Premier Dental Products Co. | 1989-06-09 | Traditional | PDF ↗ |
| K875339 | JETPOLISHER AIRPOLISHING POWDER | Young Dental Manufacturing Co. 1, LLC | 1988-04-18 | Traditional | PDF ↗ |
| K873686 | DIAMOND-LUSTER DENTAL POLISHING PASTE | Scientific Pharmaceuticals, Inc. | 1987-11-12 | Traditional | PDF ↗ |
| K872251 | ABRASIVE DISC - POLISHING WHEEL | Dentsply Intl. | 1987-07-02 | Traditional | PDF ↗ |
| K864226 | JOHNSON & JOHNSON STAINING REMOVING COMPOUND | Johnson & Johnson Professionals, Inc. | 1987-05-01 | Traditional | PDF ↗ |
| K865082 | PROPHY CARE SOLUTION | Imd, Inc. | 1987-02-12 | Traditional | PDF ↗ |
| K864215 | PROPHY CARE SOLUTION | Imd, Inc. | 1986-11-18 | Traditional | PDF ↗ |
| K863133 | PROPHY CARE PASTE | Imd, Inc. | 1986-09-25 | Traditional | PDF ↗ |
| K862912 | RENAMELIZE POLISHING PASTE | Cosmedent, Inc. | 1986-08-12 | Traditional | PDF ↗ |
| K860843 | CHECK-UP PLAQUE FIGHTING GUM | Minnetonka, Inc. | 1986-05-21 | Traditional | PDF ↗ |
| K854828 | SCI-PRO, PROPHYLAXIS PASTE | Scientific Pharmaceuticals, Inc. | 1986-03-26 | Traditional | PDF ↗ |
| K854829 | DENSCO PROPHY PASTE | Scientific Pharmaceuticals, Inc. | 1986-03-25 | Traditional | PDF ↗ |
| K854588 | INSTA-GLAZE | George Taub Products & Fusion Co., Inc. | 1986-02-04 | Traditional | PDF ↗ |
| K851073 | CUPRIDENT | Bio Systems, Inc. | 1985-07-31 | Traditional | PDF ↗ |
| K852814 | GLOSSY POLISHING PASTE | Scientific Pharmaceuticals, Inc. | 1985-07-31 | Traditional | PDF ↗ |
| K852157 | TEMREX DENTAL POLISHING PASTE | Scientific Pharmaceuticals, Inc. | 1985-07-19 | Traditional | PDF ↗ |
| K852489 | PROPOL DENTAL POLISHING PASTE | Scientific Pharmaceuticals, Inc. | 1985-07-01 | Traditional | PDF ↗ |
| K843022 | KERR COMMAND ULTRAFINE POLISHING PASTE | Kerr Corporation (Danbury) | 1984-08-24 | Traditional | PDF ↗ |
| K842403 | LUSTER, DENTAL POLISHING PASTE | Scientific Pharmaceuticals, Inc. | 1984-08-17 | Traditional | PDF ↗ |
| K840254 | DIAMOND LUSTRE | Jelrus Technical Products Corp. | 1984-04-25 | Traditional | PDF ↗ |
| K822894 | DIABRITE | Antraco, Inc. | 1982-10-18 | Traditional | PDF ↗ |
| K822142 | DIAGLAZE | Antraco, Inc. | 1982-09-14 | Traditional | PDF ↗ |
| K812118 | NIMETIC POLISHING PASTE | Espe-Premier Sales Co. | 1981-08-31 | Traditional | PDF ↗ |
| K810912 | ALLOY COMPOSITE POLISH | Moyco Industries, Inc. | 1981-04-23 | Traditional | PDF ↗ |
| K810037 | DENTAL CHEWING GUM (SUGARLESS) | Mcdennan Oral Products, Inc. | 1981-04-08 | Traditional | PDF ↗ |
| K801225 | DEN-MAT POLISHING PASTE | Den-Mat Corp. | 1980-06-17 | Traditional | PDF ↗ |
| K791319 | MIRADAPT* POLISHING INSTRUMENTS | Johnson & Johnson Professionals, Inc. | 1979-09-12 | Traditional | PDF ↗ |
| K780834 | PREVI DENT PROPHYLAXIS MINT NDC | Hoyt Laboratories | 1978-06-02 | Traditional | PDF ↗ |
| K771852 | NIMETIC POLISHING PASTE | Espe GmbH (Us) | 1977-11-02 | Traditional | PDF ↗ |
| K771401 | PROPHY PASTE | L.D. Caulk Co. | 1977-08-22 | Traditional | PDF ↗ |
| K760658 | DETARTRINE P | Septodont, Inc. | 1976-09-27 | Traditional | PDF ↗ |
| K760656 | DETARTRINE Z | Mr. J. Garrick Eisenberg | 1976-09-27 | Traditional | PDF ↗ |
Product code EJR · Class I · Dental. Data: openFDA.