Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
EFW · Predicate Candidate Screening
49 FDA 510(k) clearances under this product code; the 50 most recent screened below.
83 daysmedian FDA review time
179 days90th percentile
49clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K130186 | DENTEK EASY BRUSH WITH FLUORIDE | Den Tek Oral Care, Inc. | 2013-07-15 | 171 | 0 |
| K121165 | BEAM BRUSH/BEAM APP | Beam Technologies, LLC | 2012-06-21 | 65 | 0 |
| K102871 | SILVER CARE ANITBACTERIAL TOOTHBRUSH | Piave Spazzolificio S.P.A. | 2011-10-03 | 368 | 1 |
| K073224 | ORAL-B SUB-BRAND MANUAL TOOTHBRUSH | Procter & Gamble | 2008-02-06 | 83 | 0 |
| K021383 | ZEODYNE TOOTHBRUSH WITH AGION ANTIMICROBIAL | Agion Technologies, LLC | 2002-07-17 | 76 | 0 |
| K020776 | MEDORAL HYGIENIC TOOTHBRUSH WITH DENTOSAN FILAMENTS | Coronet Group North America, LLC | 2002-06-03 | 84 | 0 |
| K000290 | LAZERSMILE, LAZERWHITE | Biolase Technology, Inc. | 2000-04-14 | 74 | 0 |
| K994144 | TOOTHBRUSH WASH | Cal Huech, Inc. | 2000-03-02 | 86 | 0 |
| K992435 | BACTI-STOP TOOTHBRUSH CLEANER AND SANITIZER | Azo Enterprises | 1999-10-15 | 85 | 0 |
| K980995 | PLAQ-ATAQ-I | Ethicare | 1998-08-20 | 174 | 0 |
| K974761 | BUTLER ANTIBACTERIAL INTERDENTAL TOOTHBRUSH | John O. Butler Co. | 1998-06-16 | 179 | 0 |
| K973236 | CREST TOOTHBRUSH WITH MICROSHIELD | Procter & Gamble Co. | 1998-03-11 | 195 | 0 |
| K971589 | REACH ANTIBACTERIAL TOOTHBRUSH | Personal Products Co. | 1997-07-24 | 84 | 0 |
| K955530 | RANIR HI-TECHNOLOGY DENTAL FLOSS | Ranir/Dcp Corp. | 1995-12-28 | 24 | 0 |
| K950993 | BUTLER G.U.M. ANTIBACTERIAL TOOTHBRUSH | John O. Butler | 1995-06-02 | 91 | 0 |
| K930869 | ECO TOOTHBRUSH | Recycla-Dent, Inc. | 1993-05-06 | 76 | 0 |
| K905090 | FEEL FRESH TOOTHBRUSH KIT | Fresh Appeal , Ltd. | 1991-01-25 | 72 | 0 |
| K901994 | ROSOFSKY & ROSS MOUTHSPA ORAL CARE SYSTEM | Rosofsky & Ross, Inc. | 1990-07-31 | 90 | 0 |
| K892264 | ORALCHEK SUPER-SOFT BRUSH | Pfizer, Inc. | 1989-06-14 | 70 | 0 |
| K882572 | DOCTOR KOLYNOS TOOTHBRUSH | Whitehall Laboratories, Inc. | 1989-04-17 | 299 | 0 |
| K890812 | HEADS TRUE BRUSH | Mcs Trading Co. | 1989-03-17 | 29 | 0 |
| K883761 | IONODENT II (6 VOLTS) | U.S. Apatite Corp. | 1988-12-05 | 90 | 0 |
| K874443 | IONODENT (TOOTHBRUSH) | U.S. Apatite Corp. | 1988-07-19 | 265 | 0 |
| K880485 | XENEX DENTAL ROULETTE | G & A Industries, Inc. | 1988-05-02 | 88 | 0 |
| K873317 | EZ BRUSH & FLOSS | Ez Products, Ltd. | 1988-01-19 | 153 | 0 |
| K871879 | SOFSWAB | Plastic Engineered Products Co. | 1987-07-28 | 75 | 0 |
| K870414 | QUIK-BRUSH | Intl. Medication Systems, Ltd. | 1987-06-11 | 128 | 0 |
| K871359 | CHECK-MATE AND CHECK-MATE [+] | Veritech, Inc. | 1987-05-29 | 53 | 0 |
| K870906 | CARERITE INTERDENTAL BRUSHES, MODELS 3500 & 4500 | Cost Rite Health Products, Inc. | 1987-03-30 | 25 | 0 |
| K864455 | THE EXPERIMENTAL | Martin H. Kaufmann | 1987-03-18 | 126 | 0 |
| K852691 | ODONTO TOOTHBRUSH | Action Hygiene Products, Inc. | 1985-09-27 | 93 | 0 |
| K852400 | PLAK SMACKER | Plak Smacker Toothbrush Co. | 1985-07-01 | 25 | 0 |
| K833815 | ZACT DENTAL ARCH TOOTHBRUSCH | Jfc International, Inc. | 1984-02-10 | 100 | 0 |
| K834580 | REACH* TOOTHBRUSH | Johnson & Johnson Professionals, Inc. | 1984-02-10 | 43 | 0 |
| K812361 | PORTABLE TOOTHBRUSH KIT (NO SAMPLE) | Jdm Commodities | 1981-11-20 | 92 | 0 |
| K812362 | DISP. TOOTHBRUSH W/3 G. TUBE OF TOOTHPST | Jdm Commodities | 1981-11-20 | 92 | 0 |
| K812363 | DISP. TOOTHBRUSH W/TOOTHPASTE ATTACHED | Jdm Commodities | 1981-11-20 | 92 | 0 |
| K812364 | PORT. TOOTHBRUSH KIT W/4 G. TOOTHPASTE | Jdm Commodities | 1981-11-20 | 92 | 0 |
| K800831 | PY-CO-PROX TM DENTAL BRUSH | Block Drug Company, Inc. | 1980-05-08 | 24 | 0 |
| K800154 | TOTE-BRUSH | Anja Marketing, Inc. | 1980-02-05 | 13 | 0 |
| K781962 | DIJI-DENT | J&J Technologies, Inc. | 1978-12-20 | 29 | 0 |
| K781018 | DX TOOTHBRUSH | Lever Brothers Company, Inc. | 1978-06-30 | 14 | 0 |
| K771183 | TOOTHBRUSH, PEDODONTIC, #0126-0188-00 | Hoyt Laboratories | 1977-07-15 | 16 | 0 |
| K771184 | TOOTHBRUSH, ORTHODONTIC, #0126-0189-00 | Hoyt Laboratories | 1977-07-15 | 16 | 0 |
| K771185 | PERIODONTIC TOOTHBRUSH, #0126-0190-00 | Hoyt Laboratories | 1977-07-15 | 16 | 0 |
| K770749 | TOOTHBRUSH, REACH | Johnson & Johnson Professionals, Inc. | 1977-06-20 | 56 | 0 |
| K770464 | TOOTHBRUSH, PLAK-A-DENT | Smith, Ranscht, Pollock, Manos & Connor | 1977-04-08 | 35 | 0 |
| K761352 | DENTAL STAIN REMOVER | Concept, Inc. | 1977-01-03 | 6 | 0 |
| K760512 | TOOTHBRUSH | Asset Scientific & Pharmaceutical, Inc. | 1976-09-03 | 10 | 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