510(k) K191041
K191041 is an FDA 510(k) premarket notification submitted by Gni Co., Ltd. for the device "Orthodontic Fixation Screw [Smart Anchor Miniscrew]". The FDA issued a decision of Substantially Equivalent on August 28, 2020. The device falls under product code OAT (Implant, Endosseous, Orthodontic), a Class II device regulated under 21 CFR 872.3640. Gni Co., Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 28, 2020
- Date Received
- April 19, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Implant, Endosseous, Orthodontic
- Device Class
- Class II
- Regulation Number
- 872.3640
- Review Panel
- DE
- Submission Type
It is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed.