K222253 is an FDA 510(k) clearance for the GlasIonomer FX ULTRA. This device is classified as a Cement, Dental (Class II - Special Controls, product code EMA).
Submitted by Shofu Dental Corporation (San Marcos, US). The FDA issued a Cleared decision on September 22, 2022, 57 days after receiving the submission on July 27, 2022.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3275.
| 510(k) Number | K222253 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 27, 2022 |
| Decision Date | September 22, 2022 |
| Days to Decision | 57 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | EMA — Cement, Dental |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3275 |