The following data is part of a premarket notification filed by Dentek Oral Care, Inc. with the FDA for Den Tek Nightguard.
| Device ID | K063483 |
| 510k Number | K063483 |
| Device Name: | DEN TEK NIGHTGUARD |
| Classification | Mouthguard, Prescription |
| Applicant | DENTEK ORAL CARE, INC. 555 THIRTEENTH STREET, NW Washington, DC 20004 |
| Contact | Jeffrey Shapiro |
| Correspondent | Jeffrey Shapiro DENTEK ORAL CARE, INC. 555 THIRTEENTH STREET, NW Washington, DC 20004 |
| Product Code | MQC |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-17 |
| Decision Date | 2007-01-23 |
| Summary: | summary |