EFW · Toothbrush, Manual
Dental · 21 CFR 872.6855 · Class 1
Overview
| Product Code | EFW |
|---|---|
| Device Name | Toothbrush, Manual |
| Regulation | 21 CFR 872.6855 |
| Device Class | Class 1 |
| Review Panel | Dental |
| GMP Exempt | Yes |
Identification
A manual toothbrush is a device composed of a shaft with either natural or synthetic bristles at one end intended to remove adherent plaque and food debris from the teeth to reduce tooth decay.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (20 of 49)
Showing 20 most recent of 49 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K130186 | DENTEK EASY BRUSH WITH FLUORIDE | Den Tek Oral Care, Inc. | Jul 15, 2013 | SESE |
| K121165 | BEAM BRUSH/BEAM APP | Beam Technologies, LLC | Jun 21, 2012 | SESE |
| K102871 | SILVER CARE ANITBACTERIAL TOOTHBRUSH | Piave Spazzolificio S.P.A. | Oct 3, 2011 | SESE |
| K073224 | ORAL-B SUB-BRAND MANUAL TOOTHBRUSH | Procter & Gamble | Feb 6, 2008 | SESE |
| K021383 | ZEODYNE TOOTHBRUSH WITH AGION ANTIMICROBIAL | Agion Technologies, LLC | Jul 17, 2002 | SESE |
| K020776 | MEDORAL HYGIENIC TOOTHBRUSH WITH DENTOSAN FILAMENTS | Coronet Group North America, LLC | Jun 3, 2002 | SESE |
| K000290 | LAZERSMILE, LAZERWHITE | Biolase Technology, Inc. | Apr 14, 2000 | SESE |
| K994144 | TOOTHBRUSH WASH | Cal Huech, Inc. | Mar 2, 2000 | SESE |
| K992435 | BACTI-STOP TOOTHBRUSH CLEANER AND SANITIZER | Azo Enterprises | Oct 15, 1999 | SESE |
| K980995 | PLAQ-ATAQ-I | Ethicare | Aug 20, 1998 | SESE |
| K974761 | BUTLER ANTIBACTERIAL INTERDENTAL TOOTHBRUSH | John O. Butler Co. | Jun 16, 1998 | SESE |
| K973236 | CREST TOOTHBRUSH WITH MICROSHIELD | Procter & Gamble Co. | Mar 11, 1998 | SESE |
| K971589 | REACH ANTIBACTERIAL TOOTHBRUSH | Personal Products Co. | Jul 24, 1997 | SESE |
| K955530 | RANIR HI-TECHNOLOGY DENTAL FLOSS | Ranir/Dcp Corp. | Dec 28, 1995 | SESE |
| K950993 | BUTLER G.U.M. ANTIBACTERIAL TOOTHBRUSH | John O. Butler | Jun 2, 1995 | SESE |
| K930869 | ECO TOOTHBRUSH | Recycla-Dent, Inc. | May 6, 1993 | SESE |
| K905090 | FEEL FRESH TOOTHBRUSH KIT | Fresh Appeal , Ltd. | Jan 25, 1991 | SESE |
| K901994 | ROSOFSKY & ROSS MOUTHSPA ORAL CARE SYSTEM | Rosofsky & Ross, Inc. | Jul 31, 1990 | SEKD |
| K892264 | ORALCHEK SUPER-SOFT BRUSH | Pfizer, Inc. | Jun 14, 1989 | SESE |
| K882572 | DOCTOR KOLYNOS TOOTHBRUSH | Whitehall Laboratories, Inc. | Apr 17, 1989 | SESE |
Top Applicants
- Jdm Commodities — 4 clearances
- Hoyt Laboratories — 3 clearances
- Johnson & Johnson Professionals, Inc. — 2 clearances
- U.S. Apatite Corp. — 2 clearances
- Action Hygiene Products, Inc. — 1 clearance
