K153534 is an FDA 510(k) clearance for the NobelProcera HT ML Full Contour Zirconia Crown. 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 June 6, 2016, 180 days after receiving the submission on December 9, 2015.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3920.
| 510(k) Number | K153534 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 09, 2015 |
| Decision Date | June 06, 2016 |
| Days to Decision | 180 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 |