The following data is part of a premarket notification filed by Cosmedent, Inc. with the FDA for Primosplint System.
| Device ID | K030832 |
| 510k Number | K030832 |
| Device Name: | PRIMOSPLINT SYSTEM |
| Classification | Mouthguard, Prescription |
| Applicant | COSMEDENT, INC. 401 NORTH MICHIGAN AVE. SUITE 2500 Chicago, IL 60611 |
| Contact | Michael O'malley |
| Correspondent | Michael O'malley COSMEDENT, INC. 401 NORTH MICHIGAN AVE. SUITE 2500 Chicago, IL 60611 |
| 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 | 2003-03-17 |
| Decision Date | 2003-09-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D831PSKIT1 | K030832 | 000 |
| D831PS204US0 | K030832 | 000 |
| D831PS202US0 | K030832 | 000 |
| D831PS100US1 | K030832 | 000 |
| EDEL13700300 | K030832 | 000 |
| EDEL13700200 | K030832 | 000 |
| EDEL13700100 | K030832 | 000 |