The following data is part of a premarket notification filed by Osstem Implant Co.,ltd with the FDA for Orthodontic Screw.
| Device ID | K103105 |
| 510k Number | K103105 |
| Device Name: | ORTHODONTIC SCREW |
| Classification | Implant, Endosseous, Orthodontic |
| 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 | OAT |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-20 |
| Decision Date | 2011-03-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809917110497 | K103105 | 000 |
| 08809917109576 | K103105 | 000 |
| 08809917109620 | K103105 | 000 |
| 08809917109668 | K103105 | 000 |
| 08809917109705 | K103105 | 000 |
| 08809917109750 | K103105 | 000 |
| 08809917109798 | K103105 | 000 |
| 08809917109835 | K103105 | 000 |
| 08809917110114 | K103105 | 000 |
| 08809917110169 | K103105 | 000 |
| 08809917110244 | K103105 | 000 |
| 08809917110329 | K103105 | 000 |
| 08809917110374 | K103105 | 000 |
| 08809917110411 | K103105 | 000 |
| 08809917110459 | K103105 | 000 |
| 08809917109552 | K103105 | 000 |