The following data is part of a premarket notification filed by Wilde-usa, Inc. with the FDA for Compacolor.
| Device ID | K923472 |
| 510k Number | K923472 |
| Device Name: | COMPACOLOR |
| Classification | Material, Tooth Shade, Resin |
| Applicant | WILDE-USA, INC. 1819 SO. MAY ST. UNIT 2F Chicago, IL 60608 |
| Contact | Robert Bauer |
| Correspondent | Robert Bauer WILDE-USA, INC. 1819 SO. MAY ST. UNIT 2F Chicago, IL 60608 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-14 |
| Decision Date | 1992-10-13 |