K190662 is an FDA 510(k) clearance for the MRI Compatibility for Existing Straumann Dental Implant Systems. This device is classified as a Implant, Endosseous, Root-form (Class II - Special Controls, product code DZE).
Submitted by Straumann USA, LLC (Andover, US). The FDA issued a Cleared decision on June 17, 2019, 94 days after receiving the submission on March 15, 2019.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3640.
| 510(k) Number | K190662 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 15, 2019 |
| Decision Date | June 17, 2019 |
| Days to Decision | 94 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | DZE — Implant, Endosseous, Root-form |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3640 |