The following data is part of a premarket notification filed by Osstem Implant Co.,ltd with the FDA for Ms System (provisional).
| Device ID | K072871 |
| 510k Number | K072871 |
| Device Name: | MS SYSTEM (PROVISIONAL) |
| Classification | Implant, Endosseous, Root-form |
| Applicant | OSSTEM IMPLANT CO.,LTD 5536 TROWBRIDGE DRIVE Dunwoody, GA 30338 |
| Contact | Cathryn N Cambria |
| Correspondent | Cathryn N Cambria OSSTEM IMPLANT CO.,LTD 5536 TROWBRIDGE DRIVE Dunwoody, GA 30338 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-10-09 |
| Decision Date | 2008-01-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800000908014 | K072871 | 000 |
| 08809892359317 | K072871 | 000 |