EJBClass I
Handle, Instrument, Dental
21 CFR 872.4565 / Dental
EJB is the FDA product code for Handle, Instrument, Dental, a class I device type, regulated under 21 CFR 872.4565. As of , FDA records hold 8 510(k) clearances under this code, the most recent dated , and one recall.
Classification record
- Product code
- EJB
- Device name
- Handle, Instrument, Dental
- Regulation
- 21 CFR 872.4565
- Device class
- Class I
- Review panel
- Dental
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 8
- Ingested recalls
- 1
Clearances, product code EJB
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1983 | 2 |
| 1987 | 1 |
| 1992 | 1 |
| 1993 | 1 |
| 1998 | 1 |
| 2003 | 1 |
| 2014 | 1 |
Applicants with the most clearances
Product code EJB| Applicant | Clearances |
|---|---|
| Aukland Medical Plastics, Inc. | 1 |
| Centrix, Inc. | 1 |
| E&D Dental Products, Inc. | 1 |
| Joel Lander D.D.S. | 1 |
| Lone Star Technologies | 1 |
| Military Engineering, Inc. | 1 |
| Neks Technologies, Inc. | 1 |
| Treace Medical, Inc. | 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.