510(k) K250487
K250487 is an FDA 510(k) premarket notification submitted by Ormco Corporation for the device "SparkTM Clear Aligner System". The FDA issued a decision of Substantially Equivalent on February 20, 2025. The device falls under product code NXC (Aligner, Sequential), a Class II device regulated under 21 CFR 872.5470. Ormco Corporation has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 20, 2025
- Date Received
- February 19, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
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.