EFWClass I
Toothbrush, Manual
21 CFR 872.6855 / Dental
EFW is the FDA product code for Toothbrush, Manual, a class I device type, regulated under 21 CFR 872.6855. As of , FDA records hold 49 510(k) clearances under this code, the most recent dated , and 5 recalls.
Classification record
- Product code
- EFW
- Device name
- Toothbrush, Manual
- Regulation
- 21 CFR 872.6855
- Device class
- Class I
- Review panel
- Dental
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- Yes
- Third party review eligible
- No
- Ingested clearances
- 49
- Ingested recalls
- 5
Clearances, product code EFW
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1976 | 1 |
| 1977 | 6 |
| 1978 | 2 |
| 1980 | 2 |
| 1981 | 4 |
| 1984 | 2 |
| 1985 | 2 |
| 1987 | 5 |
| 1988 | 4 |
| 1989 | 3 |
| 1990 | 1 |
| 1991 | 1 |
| 1993 | 1 |
| 1995 | 2 |
| 1997 | 1 |
| 1998 | 3 |
| 1999 | 1 |
| 2000 | 2 |
| 2002 | 2 |
| 2008 | 1 |
| 2011 | 1 |
| 2012 | 1 |
| 2013 | 1 |
Applicants with the most clearances
Product code EFW| Applicant | Clearances |
|---|---|
| Jdm Commodities | 4 |
| Hoyt Laboratories | 3 |
| John O. Butler Co. | 2 |
| Johnson & Johnson Professionals, Inc. | 2 |
| Procter & Gamble Co. | 2 |
| U.S. Apatite Corp. | 2 |
| Action Hygiene Products, Inc. | 1 |
| Agion Technologies, LLC | 1 |
| Anja Marketing, Inc. | 1 |
| Asset Scientific & Pharmaceutical, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this code- 3D Dental Desings and Development
- Aboel Electronic Technology (Shenzhen) Co.,Ltd
- Acumen Houseware Industry (Nanning) Co., Ltd.
- Acumen Houseware Industry (Vietnam) Co., Ltd
- Acute Ideas Co., Ltd.
- Advanced Concept Innovations LLC
- Adwin Korea Corp.
- Aid United International Co., Limited
- Aitec Co., Ltd.
- Alfa Products USA Corp.
- Alfresa Pharma Corporation
- Amden Corp.
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
