The following data is part of a premarket notification filed by Prismatik Dentalcraft, Inc. with the FDA for Silent Nite Sleep Appliance With The Glidewell Hinge.
| Device ID | K210694 |
| 510k Number | K210694 |
| Device Name: | Silent Nite Sleep Appliance With The Glidewell Hinge |
| Classification | Device, Anti-snoring |
| Applicant | Prismatik Dentalcraft, Inc. 2144 Michelson Drive Irvine, CA 96212 |
| Contact | Herbert Schoenhoefer |
| Correspondent | Patsy J Trisler Qserve Group US, Inc. 7949 Beaumont Green East Drive Indianapolis, IN 46250 |
| Product Code | LRK |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-08 |
| Decision Date | 2021-06-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D745SNGLHGXPHU0 | K210694 | 000 |
| D745SNGLHGXPHL0 | K210694 | 000 |
| D745SNGLHGXP0 | K210694 | 000 |
| D745SNGLHGHU0 | K210694 | 000 |
| D745SNGLHGHL0 | K210694 | 000 |
| D745SNGLHGADJ0 | K210694 | 000 |
| D745SNGLHG0 | K210694 | 000 |