The following data is part of a premarket notification filed by Dental Choice Holdings, Llc with the FDA for Custmbite Dental Guard.
| Device ID | K183315 |
| 510k Number | K183315 |
| Device Name: | CustMBite Dental Guard |
| Classification | Mouthguard, Over-the-counter |
| Applicant | Dental Choice Holdings, LLC 10100 Linn Station Road Louisville, KY 40223 |
| Contact | Ron Story |
| Correspondent | E.j. Smith Smith Associates 1468 Harwell Avenue Crofton, MD 21114 |
| Product Code | OBR |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-30 |
| Decision Date | 2019-08-23 |