K210228 is an FDA 510(k) clearance for the KLS Martin IPS Preprosthetic. This device is classified as a Implant, Subperiosteal (Class II - Special Controls, product code ELE).
Submitted by KLS-Martin L.P. (Jacksonville, US). The FDA issued a Cleared decision on July 8, 2022, 526 days after receiving the submission on January 28, 2021.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3645.
| 510(k) Number | K210228 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 28, 2021 |
| Decision Date | July 08, 2022 |
| Days to Decision | 526 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | ELE — Implant, Subperiosteal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3645 |