K210473 is an FDA 510(k) clearance for the Nova Glass Cements (Nova Glass L, Nova Glass F, Nova Glass LC, Nova Glass BF, Nova Glass L Plus). This device is classified as a Cement, Dental (Class II - Special Controls, product code EMA).
Submitted by Imicryl Dis Malzemeleri Sanayi VE Ticaret AS (Konya, TR). The FDA issued a Cleared decision on November 2, 2021, 258 days after receiving the submission on February 17, 2021.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3275.
| 510(k) Number | K210473 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 17, 2021 |
| Decision Date | November 02, 2021 |
| Days to Decision | 258 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EMA - Cement, Dental |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3275 |