K251587 is an FDA 510(k) clearance for the VITA VMLC Primer. This device is classified as a Agent, Tooth Bonding, Resin (Class II - Special Controls, product code KLE).
Submitted by Vita Zahnfabrik H. Rauter GmbH & Co. Kg. (Baden-Wurttemberg, DE). The FDA issued a Cleared decision on February 23, 2026, 276 days after receiving the submission on May 23, 2025.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3200.
| 510(k) Number | K251587 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 23, 2025 |
| Decision Date | February 23, 2026 |
| Days to Decision | 276 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | KLE - Agent, Tooth Bonding, Resin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3200 |