510(k) K093821
K093821 is an FDA 510(k) premarket notification submitted by Allesee Orthodontic Appliances for the device "FS ALIGNER". The FDA issued a decision of Substantially Equivalent on August 27, 2010. The device falls under product code NXC (Aligner, Sequential), a Class II device regulated under 21 CFR 872.5470. Allesee Orthodontic Appliances has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 27, 2010
- Date Received
- December 14, 2009
- 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.