The following data is part of a premarket notification filed by Dio Department Dsi, Inc. with the FDA for Dio Biotite-h Implant System.
| Device ID | K073070 |
| 510k Number | K073070 |
| Device Name: | DIO BIOTITE-H IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | DIO DEPARTMENT DSI, INC. 13340 E. FIRESTONE BLVD SUITE J Santa Fe Springs, CA 90670 |
| Contact | Steve Chang |
| Correspondent | Steve Chang 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 | 2007-10-30 |
| Decision Date | 2008-05-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08806195922149 | K073070 | 000 |
| 08806195922002 | K073070 | 000 |
| 08806195922019 | K073070 | 000 |
| 08806195922026 | K073070 | 000 |
| 08806195922033 | K073070 | 000 |
| 08806195922057 | K073070 | 000 |
| 08806195922064 | K073070 | 000 |
| 08806195922088 | K073070 | 000 |
| 08806195922095 | K073070 | 000 |
| 08806195922101 | K073070 | 000 |
| 08806195922118 | K073070 | 000 |
| 08806195922125 | K073070 | 000 |
| 08806195922132 | K073070 | 000 |
| 08806195921999 | K073070 | 000 |