The following data is part of a premarket notification filed by Osstem Implant Co., Ltd. with the FDA for Orthodontic Screw.
| Device ID | K161197 |
| 510k Number | K161197 |
| Device Name: | Orthodontic Screw |
| Classification | Implant, Endosseous, Orthodontic |
| Applicant | OSSTEM IMPLANT CO., LTD. 66-16, BANSONG-RO 513BEON-GIL, HAEUNDAE-GU Busan, KR 612-070 |
| Contact | Na Heekwon |
| Correspondent | David Kim HIOSSEN INC. 85 BEN FAIRLESS DR. Fairless Hills, PA 19030 |
| Product Code | OAT |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-28 |
| Decision Date | 2016-12-21 |
| Summary: | summary |