K222357 is an FDA 510(k) clearance for the DenMat Glutaraldehyde Desensitizer. This device is classified as a Agent, Tooth Bonding, Resin (Class II - Special Controls, product code KLE).
Submitted by Denmat Holding, LLC (Lompoc, US). The FDA issued a Cleared decision on August 9, 2022, 5 days after receiving the submission on August 4, 2022.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3200.
| 510(k) Number | K222357 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 04, 2022 |
| Decision Date | August 09, 2022 |
| Days to Decision | 5 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 |