The following data is part of a premarket notification filed by Dental Choice Holdings Llc with the FDA for Custmbite Snoring System.
| Device ID | K221322 |
| 510k Number | K221322 |
| Device Name: | CUSTMBITE Snoring System |
| Classification | Device, Anti-snoring |
| Applicant | Dental Choice Holdings LLC 10100 Linn Station Road Louisville, KY 40223 |
| Contact | Danielle M Jackson |
| Correspondent | Yolanda Smith Smith Associates 1468 Harwell Ave. Crofton, MD 21114 |
| Product Code | LRK |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-05-06 |
| Decision Date | 2022-10-27 |