The following data is part of a premarket notification filed by Gni Co., Ltd with the FDA for Orthodontic Fixation Screw [smart Anchor Miniscrew].
| Device ID | K191041 |
| 510k Number | K191041 |
| Device Name: | Orthodontic Fixation Screw [Smart Anchor Miniscrew] |
| Classification | Implant, Endosseous, Orthodontic |
| Applicant | GNI Co., LTD 5F 501, 63-12 Dongtancheomdansaneop 1-RO Hwaseong, KR 18469 |
| Contact | Duk Soo Kim |
| Correspondent | Sang Hwa Myung E&M Consulting D-1474ho, 230 Simin-daero, Dongan-gu Anyang, KR 14067 |
| Product Code | OAT |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-19 |
| Decision Date | 2020-08-28 |