K132937 is an FDA 510(k) clearance for the HARVEST DENTAL POLYMER BLOCKS (ZCAD, AURORA). This device is classified as a Crown And Bridge, Temporary, Resin (Class II - Special Controls, product code EBG).
Submitted by Harvest Dental Products, LLC (Sarasota, US). The FDA issued a Cleared decision on May 21, 2014, 245 days after receiving the submission on September 18, 2013.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3770.
| 510(k) Number | K132937 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 18, 2013 |
| Decision Date | May 21, 2014 |
| Days to Decision | 245 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EBG - Crown And Bridge, Temporary, Resin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3770 |