K162043 is an FDA 510(k) clearance for the NobelProcera HT ML FCZ Bridge. This device is classified as a Teeth, Porcelain (Class II - Special Controls, product code ELL).
Submitted by Nobel Biocare AB (Goteborg, SE). The FDA issued a Cleared decision on November 22, 2016, 120 days after receiving the submission on July 25, 2016.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3920.
| 510(k) Number | K162043 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 25, 2016 |
| Decision Date | November 22, 2016 |
| Days to Decision | 120 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | ELL — Teeth, Porcelain |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3920 |