K202344 is an FDA 510(k) clearance for the TiUltra Implants and Xeal Abutments. This device is classified as a Implant, Endosseous, Root-form (Class II - Special Controls, product code DZE).
Submitted by Nobel Biocare AB (Vastra Hamngatan 1, SE). The FDA issued a Cleared decision on November 16, 2020, 90 days after receiving the submission on August 18, 2020.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3640.
| 510(k) Number | K202344 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 18, 2020 |
| Decision Date | November 16, 2020 |
| Days to Decision | 90 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 |