The following data is part of a premarket notification filed by Osstem Implant Co Ltd with the FDA for Ms Sa Implant System.
| Device ID | K122171 |
| 510k Number | K122171 |
| Device Name: | MS SA IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | OSSTEM IMPLANT CO LTD 85 BEN FAIRLESS DR. Fairless Hills, PA 19030 |
| Contact | Patrick Lim |
| Correspondent | Patrick Lim OSSTEM IMPLANT CO LTD 85 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 | 2012-07-23 |
| Decision Date | 2012-11-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800040652854 | K122171 | 000 |
| 08800040652083 | K122171 | 000 |
| 08800040652052 | K122171 | 000 |
| 08800040652045 | K122171 | 000 |
| 08800040652014 | K122171 | 000 |
| 08800040652007 | K122171 | 000 |
| 08800040651970 | K122171 | 000 |
| 08800040651963 | K122171 | 000 |
| 08800040651895 | K122171 | 000 |
| 08800040651888 | K122171 | 000 |
| 08800040651857 | K122171 | 000 |
| 08800040651840 | K122171 | 000 |
| 08800040651819 | K122171 | 000 |
| 08800040651802 | K122171 | 000 |
| 08800040651772 | K122171 | 000 |
| 08800040652090 | K122171 | 000 |
| 08800040652564 | K122171 | 000 |
| 08800040652847 | K122171 | 000 |
| 08800040652823 | K122171 | 000 |
| 08800040652816 | K122171 | 000 |
| 08800040652793 | K122171 | 000 |
| 08800040652786 | K122171 | 000 |
| 08800040652762 | K122171 | 000 |
| 08800040652755 | K122171 | 000 |
| 08800040652700 | K122171 | 000 |
| 08800040652687 | K122171 | 000 |
| 08800040652656 | K122171 | 000 |
| 08800040652632 | K122171 | 000 |
| 08800040652601 | K122171 | 000 |
| 08800040652595 | K122171 | 000 |
| 08800040652571 | K122171 | 000 |
| 08800040651765 | K122171 | 000 |