The following data is part of a premarket notification filed by Parkell, Inc. with the FDA for Smartemp X1.
| Device ID | K190930 |
| 510k Number | K190930 |
| Device Name: | SmarTemp X1 |
| Classification | Crown And Bridge, Temporary, Resin |
| 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 | EBG |
| CFR Regulation Number | 872.3770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-10 |
| Decision Date | 2019-09-05 |
| Summary: | summary |