Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JEQ — Predicate Candidate Screening
54 FDA 510(k) clearances under this product code; the 50 most recent screened below.
90 daysmedian FDA review time
177 days90th percentile
54clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K200881 | Oral-B iO Test Drive Power Brush Trial Program Kit | The Procter & Gamble Company | 2020-08-27 | 147 | 0 |
| K141018 | ORAL-B TEST DRIVE POWER BRUSH TRIAL PROGRAM KIT, ORAL-B TEST | Procter & Gamble Co. | 2014-09-15 | 147 | 0 |
| K061351 | ORAL-B SONIC COMPLETE | Braun GmbH | 2006-06-05 | 21 | 0 |
| K061199 | ORAL B PROFESSIONALCARE SERIES, ORAL B ADVANCEPOWER SERIES | Braun GmbH | 2006-05-31 | 33 | 0 |
| K040416 | SONICARE ADVANCE TOOTHBRUSH, MODEL 4900 | Philips Oral Healthcare, Inc. | 2004-07-02 | 135 | 0 |
| K022900 | BUTLER GUM VARI-CLEAN POWER TOOTHBRUSHES | John O. Butler Co. | 2002-11-14 | 72 | 0 |
| K012914 | SONICWAVE SONIC PLAQUE REMOVER | Homedics, Inc. | 2001-10-01 | 32 | 0 |
| K970381 | POWERED TOOTHBRUSH | Emjoi Action USA, Ltd. | 1997-04-18 | 74 | 0 |
| K943942 | TRAV-LER KIT | John O. Butler Co. | 1995-03-08 | 208 | 0 |
| K945248 | HUKUBA HYG ELECTRIC IONIC TOOTHBRUSH | Hukuba Dental Corp. | 1995-01-26 | 91 | 0 |
| K944084 | JENERIC/PENTRON P0WERED TOOTHBRUST | Jeneric/Pentron, Inc. | 1994-12-20 | 120 | 0 |
| K942634 | PEMBUSH | Crossroads Trading Co. | 1994-09-02 | 91 | 0 |
| K941209 | MY BEAT POWERED TOOTHBRUSH | Sanwa Components USA, Inc. | 1994-06-16 | 94 | 0 |
| K941243 | ORALSPRING PLUS BATTERY-POWERED TOOTHBRUSH | Oraline, Ltd. | 1994-06-06 | 83 | 0 |
| K940288 | WATER PIK SENSONIC PLAQUE REMOVAL INSTRUMENT | Teledyne Water Pik | 1994-05-26 | 125 | 0 |
| K935150 | SONIPLAK | American Dentronics, Inc. | 1994-05-18 | 202 | 0 |
| K935149 | SONIBRUSH | American Dentronics, Inc. | 1994-01-31 | 95 | 0 |
| K935148 | SONIFLOSS | American Dentronics, Inc. | 1994-01-31 | 95 | 0 |
| K936076 | ORAL EASE AUTOMATIC FLOSSER/POWER BRUSH | Ohio Health Care Products, Inc. | 1994-01-26 | 37 | 0 |
| K935561 | INTERPLAK HOME PLAQUE REMOVAL INSTRUMENT | Bausch & Lomb, Inc. | 1994-01-26 | 70 | 0 |
| K933829 | PULSE ELECTRIC TOOTHBRUSH | Dentatech Corp. | 1993-12-13 | 130 | 0 |
| K931360 | ELECTRIC TOOTH-BRUSH | U.S. Dentek Corp. | 1993-07-13 | 118 | 0 |
| K926247 | OMRON TRAVEL TOOTHBRUSH/PLAQUE REMOVER #HT-B005 | Omron Healthcare, Inc. | 1993-04-14 | 121 | 0 |
| K926246 | OMRON RECHARGEABLE PLAQUE REMOVAL SYSTEM #HT-B142 | Omron Healthcare, Inc. | 1993-04-14 | 121 | 0 |
| K913724 | SONEX ULTRASONIC TOOTH BRUSH | Sonex Intl., Corp. | 1992-12-28 | 496 | 0 |
| K924739 | THE DENTIST'S TOOTH POLISHER | Ranir/Dcp Corp. | 1992-11-24 | 63 | 0 |
| K921773 | TX ELECTRIC TOOTHBRUSH | Optiva Corp. | 1992-07-13 | 90 | 0 |
| K920644 | F499 DELUXE ELECTRIC TOOTH BRUSH W/ STAND | Fairform Mfg., Co., Ltd. | 1992-05-29 | 107 | 0 |
| K914198 | POWER FLOSS AND BRUSH EW 129 & EW 120 | Matsushita Electric Co. | 1991-12-18 | 90 | 0 |
| K910610 | INTERPLAK HOME PLAQUE REMOVAL INSTRUMENT | Bausch & Lomb, Inc. | 1991-07-09 | 147 | 0 |
| K903488 | MERIDIEN DENTAL SYSTEMS | Anco Merchandise Co., Ltd. | 1991-07-09 | 342 | 0 |
| K904401 | BATTERY-POWERED TOOTHBRUSH | The B & F System, Inc. | 1990-12-07 | 73 | 0 |
| K903510 | MICKEY/MINNIE MOUSE BATT. OPERATE TOOTHBRUSH | Helm Toy Corp. | 1990-09-10 | 38 | 0 |
| K901963 | OMRON TRAVEL TOOTHBRUSH, MODEL HT-B02 | Omron Marshall Products, Inc. | 1990-06-26 | 56 | 0 |
| K900766 | EPI DENT TOOTHBRUSH | Epi Mfg. | 1990-05-15 | 88 | 0 |
| K896245 | PLAK TRAC POWERED TOOTHBRUSH | Windmere Corp. | 1990-03-28 | 149 | 0 |
| K893736 | HOT BRUSH | Home Dental Care, Inc. | 1990-02-14 | 273 | 0 |
| K891694 | THE SMILE MACHINE | Brilliant Industries, Inc. | 1989-06-16 | 86 | 0 |
| K880589 | ROTA-DENT TOOTH CLEANER | Pro-Dentec | 1988-05-11 | 90 | 0 |
| K871929 | PROBRIGHT TOOTH POLISHER | Lap Investments, Inc. | 1987-07-31 | 74 | 0 |
| K871406 | THE WOOG ORABRUSH | Woog Intl. | 1987-07-07 | 90 | 0 |
| K862224 | THE WOOG AND THE WOOG D. POWERED TOOTHBRUSHES | Xouth, Inc. | 1986-09-26 | 107 | 0 |
| K860264 | SCHERER PORTABLE TOOTH POLISHER | Scherer Laboratories, Inc. | 1986-06-26 | 150 | 0 |
| K854326 | NO FLOSS FLOSSER | Rgm Assoc. | 1986-04-23 | 177 | 0 |
| K852476 | INTERPLAK | Dental Research Corp. | 1985-07-31 | 50 | 0 |
| K852279 | SUNBEAM RECHARGEABLE TOOTHBRUSH MODEL # 4201 | Northern Electric Co. Div. of Sunbeam Corp. | 1985-07-01 | 33 | 0 |
| K850562 | FLOSSAGE - ELECTRIC TOOTHFLOSSER | Mcspadden, Inc. | 1985-03-27 | 43 | 0 |
| K820537 | ULTRASONIC TOOTHBRUSH | Ultrasonic Plaque Control Laboratories | 1982-04-27 | 56 | 0 |
| K820503 | SVENSK TK/2 | Peter Martin Associates, Inc. | 1982-03-19 | 22 | 0 |
| K810666 | BRAUN TRAVEL | Gilette Medical Eval. Laboratory | 1981-04-14 | 33 | 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