The following data is part of a premarket notification filed by Dio Department Dsi, Inc. with the FDA for Sm Implant Systems.
| Device ID | K061797 |
| 510k Number | K061797 |
| Device Name: | SM IMPLANT SYSTEMS |
| Classification | Implant, Endosseous, Root-form |
| Applicant | DIO DEPARTMENT DSI, INC. 13340 E. FIRESTONE BLVD SUITE J Santa Fe Springs, CA 90670 |
| Contact | Dae Kyu Chang |
| Correspondent | Dae Kyu 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 | 2006-06-26 |
| Decision Date | 2006-09-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08806195921982 | K061797 | 000 |
| 08806195921876 | K061797 | 000 |
| 08806195921869 | K061797 | 000 |
| 08806195921852 | K061797 | 000 |
| 08806195921845 | K061797 | 000 |
| 08806195921838 | K061797 | 000 |
| 08806195921821 | K061797 | 000 |
| 08806195921814 | K061797 | 000 |
| 08806195921807 | K061797 | 000 |
| 08806195921883 | K061797 | 000 |
| 08806195921890 | K061797 | 000 |
| 08806195921975 | K061797 | 000 |
| 08806195921968 | K061797 | 000 |
| 08806195921951 | K061797 | 000 |
| 08806195921944 | K061797 | 000 |
| 08806195921937 | K061797 | 000 |
| 08806195921920 | K061797 | 000 |
| 08806195921913 | K061797 | 000 |
| 08806195921906 | K061797 | 000 |
| 08806195921791 | K061797 | 000 |