The following data is part of a premarket notification filed by Dio Department Dsi, Inc. with the FDA for Dio Protem Implant System.
| Device ID | K070568 |
| 510k Number | K070568 |
| Device Name: | DIO PROTEM IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | DIO DEPARTMENT DSI, INC. 13340 E. FIRESTONE BLVD SUITE J Santa Fe Springs, CA 90670 |
| Contact | Kenny Lim |
| Correspondent | Kenny Lim DIO DEPARTMENT DSI, INC. 13340 E. FIRESTONE BLVD SUITE J Santa Fe Springs, CA 90670 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-02-28 |
| Decision Date | 2007-05-25 |
| Summary: | summary |