EIAClass I
Unit, Operative Dental
21 CFR 872.6640 / Dental
EIA is the FDA product code for Unit, Operative Dental, a class I device type, regulated under 21 CFR 872.6640. As of , FDA records hold 285 510(k) clearances under this code, the most recent dated , and 4 recalls.
Classification record
- Product code
- EIA
- Device name
- Unit, Operative Dental
- Regulation
- 21 CFR 872.6640
- 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
- 285
- Ingested recalls
- 4
Clearances, product code EIA
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1977 | 3 |
| 1978 | 2 |
| 1979 | 1 |
| 1980 | 4 |
| 1981 | 1 |
| 1982 | 3 |
| 1983 | 1 |
| 1984 | 1 |
| 1985 | 3 |
| 1986 | 7 |
| 1988 | 4 |
| 1989 | 9 |
| 1990 | 7 |
| 1991 | 8 |
| 1992 | 1 |
| 1993 | 12 |
| 1994 | 27 |
| 1995 | 8 |
| 1996 | 9 |
| 1997 | 14 |
| 1998 | 25 |
| 1999 | 21 |
| 2000 | 14 |
| 2001 | 3 |
| 2002 | 7 |
| 2003 | 11 |
| 2004 | 9 |
| 2005 | 6 |
| 2006 | 4 |
| 2007 | 3 |
| 2008 | 6 |
| 2009 | 3 |
| 2010 | 3 |
| 2011 | 5 |
| 2012 | 2 |
| 2013 | 2 |
| 2014 | 2 |
| 2015 | 7 |
| 2016 | 4 |
| 2017 | 1 |
| 2018 | 2 |
| 2019 | 2 |
| 2020 | 1 |
| 2022 | 3 |
| 2023 | 3 |
| 2024 | 3 |
| 2025 | 7 |
| 2026 | 1 |
Applicants with the most clearances
Product code EIA| Applicant | Clearances |
|---|---|
| A-dec, Inc. | 25 |
| Aseptico, Inc. | 5 |
| KaVo Dental Technologies, LLC | 5 |
| Ace Surgical Supply Co., Inc. | 4 |
| Air Techniques, Inc. | 4 |
| Scitech Solutions, Inc. | 4 |
| Sds Dental, Inc. | 4 |
| Sirona Dental Systems GmbH | 4 |
| Trophy Radiologie | 4 |
| Alpine Dental Equipment Co. | 3 |
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.