K212533 is an FDA 510(k) clearance for the BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) 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 January 28, 2022, 170 days after receiving the submission on August 11, 2021.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3640.
| 510(k) Number | K212533 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 11, 2021 |
| Decision Date | January 28, 2022 |
| Days to Decision | 170 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 |