EFBClass I
Handpiece, Air-Powered, Dental
21 CFR 872.4200 / Dental
EFB is the FDA product code for Handpiece, Air-Powered, Dental, a class I device type, regulated under 21 CFR 872.4200. As of , FDA records hold 261 510(k) clearances under this code, the most recent dated , and 8 recalls.
Classification record
- Product code
- EFB
- Device name
- Handpiece, Air-Powered, Dental
- Regulation
- 21 CFR 872.4200
- Device class
- Class I
- Review panel
- Dental
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 262
- Ingested recalls
- 8
Clearances, product code EFB
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1976 | 3 |
| 1978 | 4 |
| 1979 | 4 |
| 1980 | 2 |
| 1982 | 2 |
| 1984 | 1 |
| 1985 | 1 |
| 1986 | 3 |
| 1987 | 2 |
| 1988 | 4 |
| 1989 | 4 |
| 1990 | 10 |
| 1991 | 6 |
| 1992 | 3 |
| 1993 | 4 |
| 1994 | 6 |
| 1995 | 17 |
| 1996 | 15 |
| 1997 | 9 |
| 1998 | 10 |
| 1999 | 8 |
| 2000 | 8 |
| 2001 | 3 |
| 2002 | 3 |
| 2003 | 5 |
| 2004 | 5 |
| 2005 | 4 |
| 2006 | 8 |
| 2007 | 12 |
| 2008 | 7 |
| 2009 | 11 |
| 2010 | 8 |
| 2011 | 4 |
| 2012 | 8 |
| 2013 | 3 |
| 2014 | 7 |
| 2015 | 7 |
| 2016 | 3 |
| 2017 | 7 |
| 2018 | 3 |
| 2019 | 3 |
| 2020 | 5 |
| 2021 | 2 |
| 2022 | 5 |
| 2023 | 4 |
| 2024 | 5 |
| 2025 | 1 |
| 2026 | 3 |
Applicants with the most clearances
Product code EFB| Applicant | Clearances |
|---|---|
| A-dec, Inc. | 19 |
| Nakanishi Inc. | 10 |
| Dentsply Intl. | 8 |
| E.M.S. - Electro Medical Systems SA | 8 |
| Micro Motors, Inc. | 7 |
| Dentalez, Inc. | 6 |
| J. Morita USA, Inc. | 5 |
| Midwest | 5 |
| Nsk Nakanishi, Inc. | 5 |
| Codent Technical Industry Co.,Ltd. | 4 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.