The following data is part of a premarket notification filed by Dental Concepts Llc. with the FDA for Dental Protector.
| Device ID | K024261 |
| 510k Number | K024261 |
| Device Name: | DENTAL PROTECTOR |
| Classification | Mouthguard, Prescription |
| Applicant | DENTAL CONCEPTS LLC. 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Howard Holstein |
| Correspondent | Howard Holstein DENTAL CONCEPTS LLC. 49 PLAIN ST. North Attleboro, MA 02760 |
| 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 | 2002-12-23 |
| Decision Date | 2003-03-26 |
| Summary: | summary |