The following data is part of a premarket notification filed by Osstem Implant Co Ltd with the FDA for Us/ss/gs System.
| Device ID | K073247 |
| 510k Number | K073247 |
| Device Name: | US/SS/GS SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | OSSTEM IMPLANT CO LTD ONE BEN FAIRLESS DR Fairless Hills, PA 19030 |
| Contact | Minjoo Kim |
| Correspondent | Minjoo Kim 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-11-19 |
| Decision Date | 2008-03-07 |
| Summary: | summary |