K180344 is an FDA 510(k) clearance for the TheraCal DC. This device is classified as a Liner, Cavity, Calcium Hydroxide (Class II - Special Controls, product code EJK).
Submitted by Bisco, Inc. (Schaumburg, US). The FDA issued a Cleared decision on April 5, 2018, 56 days after receiving the submission on February 8, 2018.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3250.
| 510(k) Number | K180344 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 08, 2018 |
| Decision Date | April 05, 2018 |
| Days to Decision | 56 days |
| Submission Type | Special |
| 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 |