K032562 is an FDA 510(k) clearance for the PROCEARA COPINGS AND PONTIC. This device is classified as a Teeth, Porcelain (Class II - Special Controls, product code ELL).
Submitted by Nobel Biocare AB (Yorba Linda, US). The FDA issued a Cleared decision on February 6, 2004, 170 days after receiving the submission on August 20, 2003.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3920.
| 510(k) Number | K032562 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 20, 2003 |
| Decision Date | February 06, 2004 |
| Days to Decision | 170 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 |