K242749 is an FDA 510(k) clearance for the TopCEM Ceramic Primer Ceramic Coupling Agent. This device is classified as a Agent, Tooth Bonding, Resin (Class II - Special Controls, product code KLE).
Submitted by Rizhao Huge Biomaterials Company, Ltd. (Rizhao, CN). The FDA issued a Cleared decision on November 8, 2024, 57 days after receiving the submission on September 12, 2024.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3200.
| 510(k) Number | K242749 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 12, 2024 |
| Decision Date | November 08, 2024 |
| Days to Decision | 57 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 |