K134021 is an FDA 510(k) clearance for the ESTEMP IMPLANT, ESTEMP CLEAR. This device is classified as a Cement, Dental (Class II - Special Controls, product code EMA).
Submitted by Spident Co., Ltd. (Fort Lee, US). The FDA issued a Cleared decision on June 10, 2014, 162 days after receiving the submission on December 30, 2013.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3275.
| 510(k) Number | K134021 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 30, 2013 |
| Decision Date | June 10, 2014 |
| Days to Decision | 162 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 |