510(k) K252931
K252931 is an FDA 510(k) premarket notification submitted by Align Technology, Inc. for the device "Invisalign® Palatal Expander System". The FDA issued a decision of Substantially Equivalent on October 23, 2025. The device falls under product code NXC (Aligner, Sequential), a Class II device regulated under 21 CFR 872.5470. Align Technology, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 23, 2025
- Date Received
- September 15, 2025
- Clearance Type
- Special
- 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.