K990667 is an FDA 510(k) clearance for the KLS-MARTIN TEMPORARY CONDYLAR IMPLANT. This device is classified as a Prosthesis, Condyle, Mandibular, Temporary (Class II - Special Controls, product code NEI).
Submitted by KLS-Martin L.P. (New Port Riche, US). The FDA issued a Cleared decision on July 27, 2001, 878 days after receiving the submission on March 2, 1999.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4770.
| 510(k) Number | K990667 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 02, 1999 |
| Decision Date | July 27, 2001 |
| Days to Decision | 878 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | NEI — Prosthesis, Condyle, Mandibular, Temporary |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.4770 |