K203072 is an FDA 510(k) clearance for the Franz Zirconia Dental Crown. This device is classified as a Teeth, Porcelain (Class II - Special Controls, product code ELL).
Submitted by Franz Biotech, Inc. (Taipei City, TW). The FDA issued a Cleared decision on January 19, 2022, 467 days after receiving the submission on October 9, 2020.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3920.
| 510(k) Number | K203072 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 09, 2020 |
| Decision Date | January 19, 2022 |
| Days to Decision | 467 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 |