The following data is part of a premarket notification filed by Wilde-usa, Inc. with the FDA for Keramail.
| Device ID | K915653 |
| 510k Number | K915653 |
| Device Name: | KERAMAIL |
| Classification | Powder, Porcelain |
| 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 | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-18 |
| Decision Date | 1993-04-08 |