The following data is part of a premarket notification filed by Dental Concepts Llc. with the FDA for Doctor's Nightguard.
| Device ID | K053580 |
| 510k Number | K053580 |
| Device Name: | DOCTOR'S NIGHTGUARD |
| Classification | Mouthguard, Prescription |
| Applicant | DENTAL CONCEPTS LLC. 555 THIRTEENTH STREET, NW Washington, DC 20004 |
| Contact | Howard M Holstein |
| Correspondent | Howard M Holstein DENTAL CONCEPTS LLC. 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 | 2005-12-22 |
| Decision Date | 2006-03-03 |
| Summary: | summary |