The following data is part of a premarket notification filed by Prismatik Dentalcraft, Inc. with the FDA for Silent Nite Sl.
| Device ID | K183270 |
| 510k Number | K183270 |
| Device Name: | Silent Nite Sl |
| Classification | Device, Anti-snoring |
| Applicant | Prismatik Dentalcraft, Inc. 2181 Dupont Dr. Irvine, CA 92612 |
| Contact | Mythili Reguraman |
| Correspondent | Mythili Reguraman Prismatik Dentalcraft, Inc. 2181 Dupont Dr. Irvine, CA 92612 |
| Product Code | LRK |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-23 |
| Decision Date | 2019-07-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D745SILNT0 | K183270 | 000 |