Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
EJR — Predicate Candidate Screening
77 FDA 510(k) clearances under this product code; the 50 most recent screened below.
82 daysmedian FDA review time
196 days90th percentile
77clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K171189 | AIR-FLOW PLUS Prophylaxis powder | E.M.S Electro Medical Systems S.A | 2017-09-11 | 140 | 0 |
| K131760 | WHIP MIX PREPPIES PLUS | Whip-Mix Corp. | 2014-03-26 | 282 | 0 |
| K121698 | NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMIN | Dentsply International, Inc. | 2012-08-06 | 59 | 0 |
| K103114 | OSSPRAY SYLC CR | Osspray, Ltd. | 2011-03-14 | 144 | 0 |
| K102053 | BUTLER CALCI-FLOR PROPHYLAXIS PASTE | Sunstar Americas, Inc. | 2011-02-03 | 196 | 0 |
| K101104 | REMIN PRO | Voco GmbH | 2010-10-21 | 184 | 0 |
| K100539 | PREVENTECH PROPHYLAXIS PASTE WITH FLUORIDE | Preventive Technologies, Inc. | 2010-06-17 | 112 | 0 |
| K070854 | GC MI PASTE PLUS | GC America, Inc. | 2007-04-12 | 15 | 0 |
| K062502 | OSSPRAY CLEANING COMPOUND | Ospray, Ltd. | 2006-12-15 | 112 | 0 |
| K062166 | ENAMEL PRO | Premier Dental Products Co. | 2006-11-21 | 116 | 0 |
| K042048 | GELATO PROPHYLAXIS PASTE | Deepak Products, Inc. | 2004-10-26 | 88 | 0 |
| K042200 | MI PASTE | GC America, Inc. | 2004-10-20 | 68 | 0 |
| K041371 | BUTLER NUCARE PROPHYLAXIS PASTE WITH NOVAMIN | Novamin Technology, Inc. | 2004-08-23 | 91 | 0 |
| K040988 | ZIRCON-F PROPHYLAXIS PASTE | Pascal Co., Inc. | 2004-07-07 | 83 | 0 |
| K033785 | PROACTIVE CARE PROPHYLAXIS PASTE WITH FLUORIDE | Discus Dental, Inc. | 2004-06-18 | 197 | 0 |
| K040661 | RADENT PROPHY PASTE | Pascal Co., Inc. | 2004-06-09 | 89 | 0 |
| K033449 | PRO-DENTEC DOUBLE-PRO PROPHYLAXIS PASTE WITH FLUOIDE FAMILY | Professional Dental Technologies Therapeutics, Inc. | 2004-01-07 | 70 | 0 |
| K024343 | BUTLER GUM PROPHY PASTE WITH NOVAMIN | Usbiomaterials Corp. | 2003-07-11 | 196 | 0 |
| K002989 | PROCLUDE | Ortek Therapeutics, Inc. | 2000-12-14 | 80 | 0 |
| K000169 | NUPRO PROPHYLAXIS PASTE WITH FLUORIDE AND TRICLOSAN | Dentsply Intl. | 2000-03-24 | 64 | 0 |
| K990482 | 3M CLINPRO PROPHY PASTE, MODEL 12611 | Minnesota Mining and Mfg. Co. | 1999-05-13 | 86 | 0 |
| K973289 | RE NU | Pacific Rim Dental, Inc. | 1999-02-09 | 525 | 0 |
| K983966 | NUPRO PROPHYLAXIS PASTE WITH FLOURIDE AND TRICLOSAN | Dentsply Intl. | 1999-01-29 | 84 | 0 |
| K962370 | PERFECT CHOICE PROPHY PASTE WITH 10% CARBAMIDE PEROXIDE | Challenge Products, Inc. | 1997-03-31 | 285 | 0 |
| K944575 | AQUAFRESH PLAQUE FIGHTING GUM | Smithkline Beecham Consumer Healthcare Products | 1994-12-15 | 87 | 0 |
| K942851 | SMILE INTEGRATED PROPHYLAXIS PASTE RINGS | Germiphene Corp. | 1994-11-04 | 141 | 0 |
| K940496 | PROPHY PASTE | Challenge Products, Inc. | 1994-04-19 | 76 | 0 |
| K935925 | VISION PROPHY PASTE WITH FLUORIDE | Block Drug Company, Inc. | 1994-01-26 | 44 | 0 |
| K933893 | VISION PROPHY PASTE WITHOUT FLUORIDE | Block Drug Company, Inc. | 1993-11-16 | 98 | 0 |
| K923675 | DENSPRO MEDIUM MINT PROPHY PASTE | Teledyne Getz | 1992-11-05 | 106 | 0 |
| K923674 | DENSPRO COARSE MINT PROPHY PASTE | Teledyne Getz | 1992-11-05 | 106 | 0 |
| K923020 | CLEANIC | Hawe Neos Dental | 1992-09-09 | 78 | 0 |
| K912945 | SATIN PROPHYLAXIS PASTE | Dentsply Intl. | 1991-09-16 | 73 | 0 |
| K905303 | ABUTMENT GLO | Implant Innovations International, Inc. | 1991-06-10 | 194 | 0 |
| K911284 | PULPDENT DIAMOND POLISH | Pulpdent Corp. | 1991-05-30 | 90 | 0 |
| K903986 | SWIRL PROPHYLAXIS PASTE | Bio-Medica Concepts | 1991-03-28 | 211 | 0 |
| K904199 | HORIZON REGULAR ETCHING GEL | Horizon Chemical Co. | 1990-12-05 | 84 | 0 |
| K901580 | PROPHY PASTE | Dentsply Intl. | 1990-09-06 | 155 | 0 |
| K903003 | MPS DIAMOND POLISHING GEL | Abrasive Technology, Inc. | 1990-08-29 | 51 | 0 |
| K896071 | ULTRA II PORCELAIN POLISHING PASTE | Shofu Dental Corp. | 1990-08-14 | 299 | 0 |
| K901873 | DEGUFILL (R) POLISHING GEL | Degussa AG | 1990-08-13 | 111 | 0 |
| K901973 | CP-3 DENTAL POLISHING MATERIAL | Gresco Products, Inc. | 1990-06-01 | 31 | 0 |
| K901052 | PULPDENT OIL FREE SURFACE PREPARATION PASTE | Pulpdent Corp. | 1990-04-16 | 42 | 0 |
| K896661 | KEN'S PROPHY GEL - REGULAR | Pulpdent Corp. | 1990-02-14 | 82 | 0 |
| K894933 | PERLIDENT | Germiphene Corp. | 1989-10-12 | 70 | 0 |
| K891536 | ENAMEL MICROABRASION COMPOUND | Premier Dental Products Co. | 1989-06-09 | 84 | 0 |
| K875339 | JETPOLISHER AIRPOLISHING POWDER | Young Dental Manufacturing Co. 1, LLC | 1988-04-18 | 110 | 0 |
| K873686 | DIAMOND-LUSTER DENTAL POLISHING PASTE | Scientific Pharmaceuticals, Inc. | 1987-11-12 | 59 | 0 |
| K872251 | ABRASIVE DISC - POLISHING WHEEL | Dentsply Intl. | 1987-07-02 | 20 | 0 |
| K864226 | JOHNSON & JOHNSON STAINING REMOVING COMPOUND | Johnson & Johnson Professionals, Inc. | 1987-05-01 | 185 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda