K134022 is an FDA 510(k) clearance for the BASE IT. This device is classified as a Liner, Cavity, Calcium Hydroxide (Class II - Special Controls, product code EJK).
Submitted by Spident Co., Ltd. (Fort Lee, US). The FDA issued a Cleared decision on June 11, 2014, 163 days after receiving the submission on December 30, 2013.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3250.
| 510(k) Number | K134022 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 30, 2013 |
| Decision Date | June 11, 2014 |
| Days to Decision | 163 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 |