K230270 is an FDA 510(k) clearance for the 3M™ VitCal Liner/Base. This device is classified as a Liner, Cavity, Calcium Hydroxide (Class II - Special Controls, product code EJK).
Submitted by 3M Espe Dental Products (Saint Paul, US). The FDA issued a Cleared decision on February 6, 2023, 6 days after receiving the submission on January 31, 2023.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3250.
| 510(k) Number | K230270 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 31, 2023 |
| Decision Date | February 06, 2023 |
| Days to Decision | 6 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EJK - Liner, Cavity, Calcium Hydroxide |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3250 |