510(k) K180107
K180107 is an FDA 510(k) premarket notification submitted by Blue Sky Bio, LLC for the device "Blue Sky Bio Aligner". The FDA issued a decision of Substantially Equivalent on February 9, 2018. The device falls under product code NXC (Aligner, Sequential), a Class II device regulated under 21 CFR 872.5470. Blue Sky Bio, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 9, 2018
- Date Received
- January 16, 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.