K102305 is an FDA 510(k) clearance for the HASS ZIRTOOTH MODEL ZORTOOTH H. ZIRTOOTH T. ZIRTOOTHC, ZIRTOOTH P. This device is classified as a Powder, Porcelain (Class II - Special Controls, product code EIH).
Submitted by Hass Corp. (Anaheim, US). The FDA issued a Cleared decision on December 3, 2010, 109 days after receiving the submission on August 16, 2010.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6660.
| 510(k) Number | K102305 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 16, 2010 |
| Decision Date | December 03, 2010 |
| Days to Decision | 109 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EIH - Powder, Porcelain |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.6660 |