K221033 is an FDA 510(k) clearance for the UniPrime A, UniPrime E, UniPrime E/C. This device is classified as a Agent, Tooth Bonding, Resin (Class II - Special Controls, product code KLE).
Submitted by S&C Polymer Silicon- Und Composite Spezialit?ten GmbH (Elmshorn, DE). The FDA issued a Cleared decision on July 6, 2022, 90 days after receiving the submission on April 7, 2022.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3200.
| 510(k) Number | K221033 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 07, 2022 |
| Decision Date | July 06, 2022 |
| Days to Decision | 90 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 |