The following data is part of a premarket notification filed by Dentium Co., Ltd. with the FDA for Simpleline Ii Model Sofx483408r, Sofx483410r Total 44 Models.
| Device ID | K102308 |
| 510k Number | K102308 |
| Device Name: | SIMPLELINE II MODEL SOFX483408R, SOFX483410R TOTAL 44 MODELS |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-16 |
| Decision Date | 2010-11-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809544906425 | K102308 | 000 |
| 08809544906418 | K102308 | 000 |
| 08809544906401 | K102308 | 000 |
| 08809162700719 | K102308 | 000 |