The following data is part of a premarket notification filed by Medtech Products Inc. with the FDA for Dentek Ultimate Dental Guard.
| Device ID | K180933 |
| 510k Number | K180933 |
| Device Name: | DenTek Ultimate Dental Guard |
| Classification | Mouthguard, Over-the-counter |
| Applicant | Medtech Products Inc. 660 White Plains Rd Suite 250 Tarrytown, NY 10591 |
| Contact | Mary Beth Fritz |
| Correspondent | Vincent Argiro Prestige Brands Holdings 660 White Plains Road Tarrytown, NY 10591 |
| 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 | 2018-04-10 |
| Decision Date | 2018-09-17 |
| Summary: | summary |