The following data is part of a premarket notification filed by Wilde-usa, Inc. with the FDA for Wilde Light Curing Composite Restorative Resins.
| Device ID | K913089 |
| 510k Number | K913089 |
| Device Name: | WILDE LIGHT CURING COMPOSITE RESTORATIVE RESINS |
| Classification | Material, Tooth Shade, Resin |
| Applicant | WILDE-USA, INC. P.O. BOX 4168 Naperville, IL 60567 |
| Contact | Robert W Bauer |
| Correspondent | Robert W Bauer WILDE-USA, INC. P.O. BOX 4168 Naperville, IL 60567 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-12 |
| Decision Date | 1992-04-21 |