K093027 is an FDA 510(k) clearance for the STRAUMANN RC TEMPORARY ABUTMENTS. This device is classified as a Implant, Endosseous, Root-form (Class II - Special Controls, product code DZE).
Submitted by Straumann USA (Andover, US). The FDA issued a Cleared decision on February 12, 2010, 136 days after receiving the submission on September 29, 2009.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3640.
| 510(k) Number | K093027 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 29, 2009 |
| Decision Date | February 12, 2010 |
| Days to Decision | 136 days |
| Submission Type | Special |
| 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 |