DZMClass I
Needle, Dental
21 CFR 872.4730 / Dental
DZM is the FDA product code for Needle, Dental, a class I device type, regulated under 21 CFR 872.4730. As of , FDA records hold 16 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- DZM
- Device name
- Needle, Dental
- Regulation
- 21 CFR 872.4730
- 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
- 0
Clearances, product code DZM
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1976 | 1 |
| 1980 | 1 |
| 1982 | 1 |
| 1984 | 1 |
| 1985 | 1 |
| 1986 | 1 |
| 1987 | 2 |
| 1989 | 1 |
| 1990 | 1 |
| 1991 | 3 |
| 1992 | 2 |
| 1999 | 1 |
Applicants with the most clearances
Product code DZM| Applicant | Clearances |
|---|---|
| Smith & Nephew, Mpl Division | 2 |
| Specialites Septodont | 2 |
| A Company, Inc. | 1 |
| Aseptic Dental Technologies, Inc. | 1 |
| Ausmedics Pty, Ltd. | 1 |
| Churchill Corp. | 1 |
| Dentsply Intl. | 1 |
| Exel Intl. | 1 |
| Fairfax Dental, Inc. | 1 |
| Health Technology Systems, 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.