The following data is part of a premarket notification filed by Sentage Corporation D/b/a/ Dental Services Group with the FDA for Dsg Relaxer Splint.
| Device ID | K022627 |
| 510k Number | K022627 |
| Device Name: | DSG RELAXER SPLINT |
| Classification | Mouthguard, Prescription |
| Applicant | SENTAGE CORPORATION D/B/A/ DENTAL SERVICES GROUP 1801 K ST. NW SUITE 1200 Washington, DC 20006 |
| Contact | G. Brent Connor |
| Correspondent | G. Brent Connor SENTAGE CORPORATION D/B/A/ DENTAL SERVICES GROUP 1801 K ST. NW SUITE 1200 Washington, DC 20006 |
| 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 | 2002-08-07 |
| Decision Date | 2003-03-18 |