The following data is part of a premarket notification filed by Cosmedent, Inc. with the FDA for Ginda Guard.
| Device ID | K011239 |
| 510k Number | K011239 |
| Device Name: | GINDA GUARD |
| Classification | Coating, Filling Material, Resin |
| Applicant | COSMEDENT, INC. 401 N. MICHIGAN AVE. SUITE 2500 Chicago, IL 60611 |
| Contact | Michael O'malley |
| Correspondent | Michael O'malley COSMEDENT, INC. 401 N. MICHIGAN AVE. SUITE 2500 Chicago, IL 60611 |
| Product Code | EBD |
| CFR Regulation Number | 872.3310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-23 |
| Decision Date | 2002-02-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D7799021010 | K011239 | 000 |