K153111 is an FDA 510(k) clearance for the TOUAREG CloseFit™ UNP 2.75mmD. This device is classified as a Implant, Endosseous, Root-form (Class II - Special Controls, product code DZE).
Submitted by Adin Dental Implants Systems , Ltd. (Afula, IL). The FDA issued a Cleared decision on May 6, 2016, 191 days after receiving the submission on October 28, 2015.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3640.
| 510(k) Number | K153111 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 28, 2015 |
| Decision Date | May 06, 2016 |
| Days to Decision | 191 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 |