K192007 is an FDA 510(k) clearance for the TheraBase, TheraBase Ca. This device is classified as a Cement, Dental (Class II - Special Controls, product code EMA).
Submitted by Bisco, Inc. (Schaumburg, US). The FDA issued a Cleared decision on March 17, 2020, 232 days after receiving the submission on July 29, 2019.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3275.
| 510(k) Number | K192007 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 29, 2019 |
| Decision Date | March 17, 2020 |
| Days to Decision | 232 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EMA — Cement, Dental |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3275 |