The following data is part of a premarket notification filed by Dentium Co., Ltd. with the FDA for Slim Onebody System.
| Device ID | K111162 |
| 510k Number | K111162 |
| Device Name: | SLIM ONEBODY SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | DENTIUM CO., LTD. 6761 KATELLA AVENUE Cypress, CA 90630 |
| Contact | Eunkyung Son |
| Correspondent | Eunkyung Son DENTIUM CO., LTD. 6761 KATELLA AVENUE Cypress, CA 90630 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-25 |
| Decision Date | 2012-01-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809691368619 | K111162 | 000 |
| 08809691365786 | K111162 | 000 |
| 08809691365779 | K111162 | 000 |
| 08809691365748 | K111162 | 000 |
| 08809691365731 | K111162 | 000 |
| 08809691365724 | K111162 | 000 |
| 08809691365694 | K111162 | 000 |
| 08809691365687 | K111162 | 000 |
| 08809691361122 | K111162 | 000 |
| 08809691368251 | K111162 | 000 |
| 08809691368268 | K111162 | 000 |
| 08809691368602 | K111162 | 000 |
| 08809691368374 | K111162 | 000 |
| 08809691368367 | K111162 | 000 |
| 08809691368350 | K111162 | 000 |
| 08809691368329 | K111162 | 000 |
| 08809691368312 | K111162 | 000 |
| 08809691368305 | K111162 | 000 |
| 08809691368275 | K111162 | 000 |
| 08809691361115 | K111162 | 000 |