The following data is part of a premarket notification filed by Osstem Implant Co.,ltd with the FDA for Gs Fixture System.
| Device ID | K072896 |
| 510k Number | K072896 |
| Device Name: | GS FIXTURE SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | OSSTEM IMPLANT CO.,LTD ONE BEN FAIRLESS DR. Fairless Hills, PA 19030 |
| Contact | Kim M Joo |
| Correspondent | Kim M Joo OSSTEM IMPLANT CO.,LTD ONE BEN FAIRLESS DR. Fairless Hills, 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 | 2007-10-11 |
| Decision Date | 2007-11-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809917094933 | K072896 | 000 |