K071182 is an FDA 510(k) clearance for the PROCERA BRIDGE ZIRCONIA 9 UNITS-14 UNITS, MODELS 30-4004 TO 30-4013. 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 July 11, 2007, 72 days after receiving the submission on April 30, 2007.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3920.
| 510(k) Number | K071182 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 30, 2007 |
| Decision Date | July 11, 2007 |
| Days to Decision | 72 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 |