DZNClass I
Instruments, Dental Hand
21 CFR 872.4565 / Dental
DZN is the FDA product code for Instruments, Dental Hand, a class I device type, regulated under 21 CFR 872.4565. As of , FDA records hold 16 510(k) clearances under this code, the most recent dated , and 2 recalls.
Classification record
- Product code
- DZN
- Device name
- Instruments, Dental Hand
- 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
- 16
- Ingested recalls
- 2
Clearances, product code DZN
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1978 | 2 |
| 1979 | 3 |
| 1980 | 3 |
| 1982 | 2 |
| 1984 | 2 |
| 1986 | 1 |
| 1990 | 1 |
| 2007 | 1 |
| 2012 | 1 |
Applicants with the most clearances
Product code DZN| Applicant | Clearances |
|---|---|
| Den-Mat Corp. | 2 |
| Howmedica Corp. | 2 |
| Accor, Inc. | 1 |
| Alvin Meyer, D.D.S. | 1 |
| Centrix, Inc. | 1 |
| Dentsply Intl. | 1 |
| Fly Cast Technologies, Inc. | 1 |
| Healthco, Inc. | 1 |
| Ivoclar North America, Inc. | 1 |
| Kerrhawe SA | 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.
