EAPClass II
Unit, X-Ray, Intraoral
21 CFR 872.1810 / Dental
EAP is the FDA product code for Unit, X-Ray, Intraoral, a class II device type, regulated under 21 CFR 872.1810. As of , FDA records hold 42 510(k) clearances under this code, the most recent dated , and 6 recalls.
Classification record
- Product code
- EAP
- Device name
- Unit, X-Ray, Intraoral
- Regulation
- 21 CFR 872.1810
- Device class
- Class II
- Review panel
- Dental
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 42
- Ingested recalls
- 6
Clearances, product code EAP
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1976 | 1 |
| 1977 | 2 |
| 1978 | 1 |
| 1979 | 1 |
| 1980 | 4 |
| 1983 | 3 |
| 1985 | 1 |
| 1986 | 1 |
| 1988 | 2 |
| 1990 | 3 |
| 1993 | 5 |
| 1994 | 3 |
| 1995 | 7 |
| 1996 | 2 |
| 2004 | 1 |
| 2005 | 1 |
| 2008 | 1 |
| 2009 | 1 |
| 2011 | 1 |
| 2012 | 1 |
Applicants with the most clearances
Product code EAP| Applicant | Clearances |
|---|---|
| Belmont Equipment Corp. | 5 |
| Keystone X-Ray, Inc. | 3 |
| KaVo Dental Technologies, LLC | 3 |
| Schick Technologies, Inc. | 3 |
| Trophy Radiologie | 3 |
| Chicago X-Ray Systems, Inc. | 2 |
| General Electric Co. | 2 |
| Pennwalt Corp. | 2 |
| Advanced Image Science, Inc. | 1 |
| Afp Imaging Corp. | 1 |
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.
