The following data is part of a premarket notification filed by Parkell, Inc. with the FDA for Parkell Desensitizer Gel.
| Device ID | K191103 |
| 510k Number | K191103 |
| Device Name: | Parkell Desensitizer Gel |
| Classification | Liner, Cavity, Calcium Hydroxide |
| Applicant | Parkell, Inc. 300 Executive Drive Edgewood, NY 11717 |
| Contact | David Mott |
| Correspondent | David Mott Parkell, Inc. 300 Executive Drive Edgewood, NY 11717 |
| Product Code | EJK |
| CFR Regulation Number | 872.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-25 |
| Decision Date | 2019-11-22 |