K191103 is an FDA 510(k) clearance for the Parkell Desensitizer Gel. This device is classified as a Liner, Cavity, Calcium Hydroxide (Class II — Special Controls, product code EJK).
Submitted by Parkell, Inc. (Edgewood, US). The FDA issued a Cleared decision on November 22, 2019, 211 days after receiving the submission on April 25, 2019.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3250.
| 510(k) Number | K191103 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 25, 2019 |
| Decision Date | November 22, 2019 |
| Days to Decision | 211 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 |