K041283 is an FDA 510(k) clearance for the PROCERA BRIDGE ZIRCONIA. 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 May 28, 2004, 15 days after receiving the submission on May 13, 2004.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3920.
| 510(k) Number | K041283 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 13, 2004 |
| Decision Date | May 28, 2004 |
| Days to Decision | 15 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 |