510(k) K260527
K260527 is an FDA 510(k) premarket notification submitted by Avinent Implant System S.L.U. for the device "FACE4D Aligner". The FDA issued a decision of Substantially Equivalent on July 2, 2026. The device falls under product code NXC (Aligner, Sequential), a Class II device regulated under 21 CFR 872.5470. Avinent Implant System S.L.U. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 2, 2026
- Date Received
- February 17, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Aligner, Sequential
- Device Class
- Class II
- Regulation Number
- 872.5470
- Review Panel
- DE
- Submission Type
The device moves the teeth by continuous gentle force for treatment of minor tooth malocclusion.