K130808 is an FDA 510(k) clearance for the STRAUMANN HEALING ABUTMENTS, HEALING CAPS, CLOSURE SCREWS. This device is classified as a Abutment, Implant, Dental, Endosseous (Class II - Special Controls, product code NHA).
Submitted by Straumann USA (Andover, US). The FDA issued a Cleared decision on June 28, 2013, 95 days after receiving the submission on March 25, 2013.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3630. To Be Used In Conjunction With An Endosseous Dental Implant Fixture To Aid In Prosthetic Rehabilitation..
| 510(k) Number | K130808 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 25, 2013 |
| Decision Date | June 28, 2013 |
| Days to Decision | 95 days |
| Submission Type | Special |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | NHA — Abutment, Implant, Dental, Endosseous |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3630 |
| Definition | To Be Used In Conjunction With An Endosseous Dental Implant Fixture To Aid In Prosthetic Rehabilitation. |