The following data is part of a premarket notification filed by Osstem Implant Co.,ltd with the FDA for Ms System (narrow Ridge).
| Device ID | K080594 |
| 510k Number | K080594 |
| Device Name: | MS SYSTEM (NARROW RIDGE) |
| 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 | 2008-03-03 |
| Decision Date | 2008-09-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814913022642 | K080594 | 000 |
| 00814913022536 | K080594 | 000 |
| 00814913022543 | K080594 | 000 |
| 00814913022550 | K080594 | 000 |
| 00814913022567 | K080594 | 000 |
| 00814913022574 | K080594 | 000 |
| 00814913022581 | K080594 | 000 |
| 00814913022598 | K080594 | 000 |
| 00814913022604 | K080594 | 000 |
| 00814913022611 | K080594 | 000 |
| 00814913022628 | K080594 | 000 |
| 00814913022635 | K080594 | 000 |
| 08800000979106 | K080594 | 000 |