KXRClass I
Applicator, Resin
21 CFR 872.3140 / Dental
KXR is the FDA product code for Applicator, Resin, a class I device type, regulated under 21 CFR 872.3140. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- KXR
- Device name
- Applicator, Resin
- Regulation
- 21 CFR 872.3140
- Device class
- Class I
- Review panel
- Dental
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- Yes
- Third party review eligible
- No
- Ingested clearances
- 3
- Ingested recalls
- 0
Clearances, product code KXR
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1977 | 1 |
| 1978 | 1 |
| 1983 | 1 |
Applicants with the most clearances
Product code KXR| Applicant | Clearances |
|---|---|
| 3M Company | 1 |
| Centrix, Inc. | 1 |
| Deringer-Ney, 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.
