K162004 is an FDA 510(k) clearance for the PREMIUM Implant Systems SHELTA Implant Systems. This device is classified as a Abutment, Implant, Dental, Endosseous (Class II - Special Controls, product code NHA).
Submitted by Sweden & Martina S.P.A. (Due Carrare, IT). The FDA issued a Cleared decision on December 5, 2016, 138 days after receiving the submission on July 20, 2016.
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 | K162004 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 20, 2016 |
| Decision Date | December 05, 2016 |
| Days to Decision | 138 days |
| Submission Type | Special |
| Review Panel | Dental (DE) |
| Summary | Statement |
| 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. |