The following data is part of a premarket notification filed by Wilde-usa, Inc. with the FDA for Wil-o-dont Orthodontic Material/wil-o-lux.
| Device ID | K920557 |
| 510k Number | K920557 |
| Device Name: | WIL-O-DONT ORTHODONTIC MATERIAL/WIL-O-LUX |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | WILDE-USA, INC. 1819 SO. MAY ST. UNIT 2F Chicago, IL 60608 |
| Contact | Robert W Bauer |
| Correspondent | Robert W Bauer WILDE-USA, INC. 1819 SO. MAY ST. UNIT 2F Chicago, IL 60608 |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-02-05 |
| Decision Date | 1992-03-20 |