The following data is part of a premarket notification filed by Dio Corporation with the FDA for Dioslimon Implant System.
| Device ID | K112746 |
| 510k Number | K112746 |
| Device Name: | DIOSLIMON IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | DIO CORPORATION 3540 WILSHIRE BLVD. SUITE 1104 Los Angeles, CA 90010 |
| Contact | Timothy Lee |
| Correspondent | Timothy Lee DIO CORPORATION 3540 WILSHIRE BLVD. SUITE 1104 Los Angeles, CA 90010 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-21 |
| Decision Date | 2011-10-21 |
| Summary: | summary |