The following data is part of a premarket notification filed by Dentek Oral Care, Inc. with the FDA for Custom Comfort Nightguard.
| Device ID | K083400 |
| 510k Number | K083400 |
| Device Name: | CUSTOM COMFORT NIGHTGUARD |
| Classification | Mouthguard, Over-the-counter |
| Applicant | DENTEK ORAL CARE, INC. 555 THIRTEENTH STREET, NW Washington, DC 20004 |
| Contact | Howard M Holstein |
| Correspondent | Howard M Holstein DENTEK ORAL CARE, INC. 555 THIRTEENTH STREET, NW Washington, DC 20004 |
| Product Code | OBR |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-17 |
| Decision Date | 2008-12-11 |
| Summary: | summary |