Product code EFW
- Device name
- Toothbrush, Manual
- Medical specialty
- Dental
- Device class
- 1
- Regulation number
- 872.6855
- Review panel
- DE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- Y
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K130186 | DENTEK EASY BRUSH WITH FLUORIDE | Den Tek Oral Care, Inc. | 2013-07-15 |
| K121165 | BEAM BRUSH/BEAM APP | Beam Technologies, LLC | 2012-06-21 |
| K102871 | SILVER CARE ANITBACTERIAL TOOTHBRUSH | Piave Spazzolificio S.P.A. | 2011-10-03 |
| K073224 | ORAL-B SUB-BRAND MANUAL TOOTHBRUSH | Procter & Gamble | 2008-02-06 |
| K021383 | ZEODYNE TOOTHBRUSH WITH AGION ANTIMICROBIAL | Agion Technologies, LLC | 2002-07-17 |
| K020776 | MEDORAL HYGIENIC TOOTHBRUSH WITH DENTOSAN FILAMENTS | Coronet Group North America, LLC | 2002-06-03 |
| K000290 | LAZERSMILE, LAZERWHITE | Biolase Technology, Inc. | 2000-04-14 |
| K994144 | TOOTHBRUSH WASH | Cal Huech, Inc. | 2000-03-02 |
| K992435 | BACTI-STOP TOOTHBRUSH CLEANER AND SANITIZER | Azo Enterprises | 1999-10-15 |
| K980995 | PLAQ-ATAQ-I | Ethicare | 1998-08-20 |
| K974761 | BUTLER ANTIBACTERIAL INTERDENTAL TOOTHBRUSH | John O. Butler Co. | 1998-06-16 |
| K973236 | CREST TOOTHBRUSH WITH MICROSHIELD | Procter & Gamble Co. | 1998-03-11 |
| K971589 | REACH ANTIBACTERIAL TOOTHBRUSH | Personal Products Co. | 1997-07-24 |
| K955530 | RANIR HI-TECHNOLOGY DENTAL FLOSS | Ranir/Dcp Corp. | 1995-12-28 |
| K950993 | BUTLER G.U.M. ANTIBACTERIAL TOOTHBRUSH | John O. Butler | 1995-06-02 |
| K930869 | ECO TOOTHBRUSH | Recycla-Dent, Inc. | 1993-05-06 |
| K905090 | FEEL FRESH TOOTHBRUSH KIT | Fresh Appeal , Ltd. | 1991-01-25 |
| K901994 | ROSOFSKY & ROSS MOUTHSPA ORAL CARE SYSTEM | Rosofsky & Ross, Inc. | 1990-07-31 |
| K892264 | ORALCHEK SUPER-SOFT BRUSH | Pfizer, Inc. | 1989-06-14 |
| K882572 | DOCTOR KOLYNOS TOOTHBRUSH | Whitehall Laboratories, Inc. | 1989-04-17 |
| K890812 | HEADS TRUE BRUSH | Mcs Trading Co. | 1989-03-17 |
| K883761 | IONODENT II (6 VOLTS) | U.S. Apatite Corp. | 1988-12-05 |
| K874443 | IONODENT (TOOTHBRUSH) | U.S. Apatite Corp. | 1988-07-19 |
| K880485 | XENEX DENTAL ROULETTE | G & A Industries, Inc. | 1988-05-02 |
| K873317 | EZ BRUSH & FLOSS | Ez Products, Ltd. | 1988-01-19 |
| K871879 | SOFSWAB | Plastic Engineered Products Co. | 1987-07-28 |
| K870414 | QUIK-BRUSH | Intl. Medication Systems, Ltd. | 1987-06-11 |
| K871359 | CHECK-MATE AND CHECK-MATE [+] | Veritech, Inc. | 1987-05-29 |
| K870906 | CARERITE INTERDENTAL BRUSHES, MODELS 3500 & 4500 | Cost Rite Health Products, Inc. | 1987-03-30 |
| K864455 | THE EXPERIMENTAL | Martin H. Kaufmann | 1987-03-18 |
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| 00072239330418 | Dr. Brown's | Dr. Brown's Company | 2025-05-22 |
| 00072239329122 | Dr. Brown's | Dr. Brown's Company | 2024-04-18 |
| 00072239328026 | Dr. Brown's | Dr. Brown's Company | 2024-04-17 |
| 00072239328019 | Dr. Brown's | Dr. Brown's Company | 2024-04-17 |
| 00072239303634 | Dr. Brown's | Dr. Brown's Company | 2022-11-30 |
| 00072239327449 | Dr. Brown's | Dr. Brown's Company | 2022-11-30 |
| 00072239327432 | Dr. Brown's | Dr. Brown's Company | 2022-11-30 |
| 00072239326480 | Dr. Brown's | Dr. Brown's Company | 2022-11-30 |
| 00072239326145 | Dr. Brown's | Dr. Brown's Company | 2022-11-30 |
| 00072239325407 | Dr. Brown's | Dr. Brown's Company | 2022-11-30 |
| 00072239318836 | Dr. Brown's | Dr. Brown's Company | 2022-11-30 |
| 00072239303627 | Dr. Brown's | Dr. Brown's Company | 2022-11-30 |
| 00072239303658 | Dr. Brown's | Dr. Brown's Company | 2022-11-30 |
| 00072239303665 | Dr. Brown's | Dr. Brown's Company | 2022-11-30 |
| 00072239325414 | Dr. Brown's | Dr. Brown's Company | 2022-11-30 |
| 00072239311141 | Dr. Brown's | Dr. Brown's Company | 2022-11-30 |
| 00072239311691 | Dr. Brown's | Dr. Brown's Company | 2022-11-30 |
| 00072239316450 | Dr. Brown's | Dr. Brown's Company | 2022-11-30 |
| 00072239316467 | Dr. Brown's | Dr. Brown's Company | 2022-11-30 |
| 00072239316764 | Dr. Brown's | Dr. Brown's Company | 2022-11-30 |
| 00072239325025 | Dr. Brown's | Dr. Brown's Company | 2022-11-30 |
| 10070942752272 | GUM® | SUNSTAR AMERICAS, INC. | 2022-11-10 |
| 10070942752289 | GUM® | SUNSTAR AMERICAS, INC. | 2022-11-10 |
| 10070942752319 | GUM® | SUNSTAR AMERICAS, INC. | 2022-11-10 |
| M368339511 | Grafco | GF HEALTH PRODUCTS, INC. | 2021-06-08 |
| M368339521 | Grafco | GF HEALTH PRODUCTS, INC. | 2021-06-08 |
| M36833961 | Grafco | GF HEALTH PRODUCTS, INC. | 2021-06-08 |
| M36833971 | Grafco | GF HEALTH PRODUCTS, INC. | 2021-06-08 |
| 10304040036584 | Henry Schein | HENRY SCHEIN, INC. | 2019-02-22 |