K190930 is an FDA 510(k) clearance for the SmarTemp X1. This device is classified as a Crown And Bridge, Temporary, Resin (Class II - Special Controls, product code EBG).
Submitted by Parkell, Inc. (Edgewood, US). The FDA issued a Cleared decision on September 5, 2019, 148 days after receiving the submission on April 10, 2019.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3770.
| 510(k) Number | K190930 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 10, 2019 |
| Decision Date | September 05, 2019 |
| Days to Decision | 148 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EBG — Crown And Bridge, Temporary, Resin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3770 |