The following data is part of a premarket notification filed by Wilde-usa, Inc. with the FDA for Keralloy-d Caps.
| Device ID | K915654 |
| 510k Number | K915654 |
| Device Name: | KERALLOY-D CAPS |
| Classification | Alloy, Amalgam |
| 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 | EJJ |
| CFR Regulation Number | 872.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-18 |
| Decision Date | 1992-03-02 |