510(k) K183643
K183643 is an FDA 510(k) premarket notification submitted by Specialty Appliance Works, Inc. for the device "Clear Image Aligners". The FDA issued a decision of Substantially Equivalent on January 3, 2019. The device falls under product code NXC (Aligner, Sequential), a Class II device regulated under 21 CFR 872.5470. Specialty Appliance Works, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 3, 2019
- Date Received
- December 26, 2018
- 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.