The following data is part of a premarket notification filed by Dio Department Dsi, Inc. with the FDA for Secure Implant System (2.5/3.0mm).
| Device ID | K080129 |
| 510k Number | K080129 |
| Device Name: | SECURE IMPLANT SYSTEM (2.5/3.0MM) |
| Classification | Implant, Endosseous, Root-form |
| Applicant | DIO DEPARTMENT DSI, INC. 3540 WILSHIRE BLVD. SUITE 1104 Los Angeles, CA 90010 |
| Contact | Hyungick Kim |
| Correspondent | Hyungick Kim DIO DEPARTMENT 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 | 2008-01-17 |
| Decision Date | 2008-05-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08806195912591 | K080129 | 000 |
| 08800049215302 | K080129 | 000 |
| 08800049215241 | K080129 | 000 |
| 08800049215180 | K080129 | 000 |
| 08800049215081 | K080129 | 000 |
| 08800049215029 | K080129 | 000 |
| 08800049214961 | K080129 | 000 |
| 08800049214909 | K080129 | 000 |
| 08800049214329 | K080129 | 000 |
| 08800049214268 | K080129 | 000 |
| 08800049214206 | K080129 | 000 |
| 08800049214145 | K080129 | 000 |
| 08800049214046 | K080129 | 000 |
| 08800049213988 | K080129 | 000 |
| 08800049213926 | K080129 | 000 |
| 08800049215364 | K080129 | 000 |
| 08806195911723 | K080129 | 000 |
| 08806195912584 | K080129 | 000 |
| 08806195912577 | K080129 | 000 |
| 08806195912560 | K080129 | 000 |
| 08806195912553 | K080129 | 000 |
| 08806195912546 | K080129 | 000 |
| 08806195912539 | K080129 | 000 |
| 08806195912522 | K080129 | 000 |
| 08806195911860 | K080129 | 000 |
| 08806195911846 | K080129 | 000 |
| 08806195911822 | K080129 | 000 |
| 08806195911808 | K080129 | 000 |
| 08806195911785 | K080129 | 000 |
| 08806195911761 | K080129 | 000 |
| 08806195911747 | K080129 | 000 |
| 08800049213865 | K080129 | 000 |