The following data is part of a premarket notification filed by Osstem Implant Co., Ltd. with the FDA for Sb Anchor.
| Device ID | K140600 |
| 510k Number | K140600 |
| Device Name: | SB ANCHOR |
| Classification | Abutment, Implant, Dental, Endosseous |
| 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 | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-10 |
| Decision Date | 2014-08-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809917157317 | K140600 | 000 |
| 08809917096180 | K140600 | 000 |
| 08809917096203 | K140600 | 000 |
| 08809917096227 | K140600 | 000 |
| 08809917096241 | K140600 | 000 |
| 08809917096265 | K140600 | 000 |
| 08809917096302 | K140600 | 000 |
| 08809917096333 | K140600 | 000 |
| 08809917096364 | K140600 | 000 |
| 08809917096388 | K140600 | 000 |
| 08809917096401 | K140600 | 000 |
| 08809917096173 | K140600 | 000 |