The following data is part of a premarket notification filed by Osstem Implant Co.,ltd with the FDA for Hu Ii / Hs Ii Fixture System.
| Device ID | K080387 |
| 510k Number | K080387 |
| Device Name: | HU II / HS II FIXTURE SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | OSSTEM IMPLANT CO.,LTD 1 BEN FAIRLESS DR. Fairless, PA 19030 |
| Contact | Min Joo Kim |
| Correspondent | Min Joo Kim OSSTEM IMPLANT CO.,LTD 1 BEN FAIRLESS DR. Fairless, PA 19030 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-13 |
| Decision Date | 2008-03-07 |
| Summary: | summary |