The following data is part of a premarket notification filed by Dsi, Inc. with the FDA for Dio Sm Implant System.
| Device ID | K080559 |
| 510k Number | K080559 |
| Device Name: | DIO SM IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | DSI, INC. 3540 WILSHIRE BLVD SUITE 1104 Los Angeles, CA 90010 |
| Contact | Hyungick Kim |
| Correspondent | Hyungick Kim DSI, INC. 3540 WILSHIRE BLVD SUITE 1104 Los Angeles, CA 90010 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-28 |
| Decision Date | 2008-10-09 |
| Summary: | summary |