The following data is part of a premarket notification filed by Dio Department Dsi, Inc. with the FDA for Sm-extra Wide (rbm) Implant System.
| Device ID | K080128 |
| 510k Number | K080128 |
| Device Name: | SM-EXTRA WIDE (RBM) IMPLANT SYSTEM |
| 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 | 2008-05-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08806195926406 | K080128 | 000 |
| 08806195926390 | K080128 | 000 |
| 08806195926383 | K080128 | 000 |
| 08806195926376 | K080128 | 000 |
| 08806195926369 | K080128 | 000 |
| 08806195926352 | K080128 | 000 |
| 08806195926345 | K080128 | 000 |
| 08806195926338 | K080128 | 000 |
| 08806195926321 | K080128 | 000 |