Submission Details
| 510(k) Number | K924155 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 18, 1992 |
| Decision Date | May 12, 1993 |
| Days to Decision | 267 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
K924155 is an FDA 510(k) clearance for the SURA SNAP, a Implant, Endosseous, Root-form (Class II — Special Controls, product code DZE), submitted by Metalor Dental USA Corp. (Rockville Centre, US). The FDA issued a Cleared decision on May 12, 1993, 267 days after receiving the submission on August 18, 1992. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.
| 510(k) Number | K924155 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 18, 1992 |
| Decision Date | May 12, 1993 |
| Days to Decision | 267 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | DZE — Implant, Endosseous, Root-form |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 872.3640 |