K233868 is an FDA 510(k) clearance for the dima Print Teeth & Temp. This device is classified as a Crown And Bridge, Temporary, Resin (Class II - Special Controls, product code EBG).
Submitted by Kulzer, LLC (South Bend, US). The FDA issued a Cleared decision on May 23, 2024, 169 days after receiving the submission on December 6, 2023.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3770.
| 510(k) Number | K233868 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 06, 2023 |
| Decision Date | May 23, 2024 |
| Days to Decision | 169 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EBG — Crown And Bridge, Temporary, Resin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3770 |