K253380 is an FDA 510(k) clearance for the “FLNT Base” and “FLNT Temp”. This device is classified as a Crown And Bridge, Temporary, Resin (Class II - Special Controls, product code EBG).
Submitted by Liaoning Upcera Co., Ltd. (Benxi, CN). The FDA issued a Cleared decision on March 2, 2026, 153 days after receiving the submission on September 30, 2025.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3770.
| 510(k) Number | K253380 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 30, 2025 |
| Decision Date | March 02, 2026 |
| Days to Decision | 153 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 |