K002790 is an FDA 510(k) clearance for the ADD-ON CONDYLE. This device is classified as a Prosthesis, Condyle, Mandibular, Temporary (Class II - Special Controls, product code NEI).
Submitted by Walter Lorenz Surgical, Inc. (Jacksonville, US). The FDA issued a Cleared decision on August 6, 2001, 333 days after receiving the submission on September 7, 2000.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4770.
| 510(k) Number | K002790 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 07, 2000 |
| Decision Date | August 06, 2001 |
| Days to Decision | 333 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 |