K230465 is an FDA 510(k) clearance for the Hi-Bond Universal. This device is classified as a Agent, Tooth Bonding, Resin (Class II - Special Controls, product code KLE).
Submitted by Mediclus Co., Ltd. (Cheongju-Si, KR). The FDA issued a Cleared decision on May 22, 2023, 90 days after receiving the submission on February 21, 2023.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3200.
| 510(k) Number | K230465 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 21, 2023 |
| Decision Date | May 22, 2023 |
| 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 |