K230108 is an FDA 510(k) clearance for the Straumann® BLC and TLC Implants. This device is classified as a Implant, Endosseous, Root-form (Class II - Special Controls, product code DZE).
Submitted by Institut Straumann AG (Basel, CH). The FDA issued a Cleared decision on September 14, 2023, 244 days after receiving the submission on January 13, 2023.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3640.
| 510(k) Number | K230108 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 13, 2023 |
| Decision Date | September 14, 2023 |
| Days to Decision | 244 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 |