510(k) K212961
K212961 is an FDA 510(k) premarket notification submitted by Biotech Dental Smilers, Sas for the device "SMILERS". The FDA issued a decision of Substantially Equivalent on Sep 20, 2021. The device falls under product code NXC (Aligner, Sequential), a Class II device regulated under 21 CFR 872.5470.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 20, 2021
- Date Received
- Sep 16, 2021
- 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
- 510(k)
The device moves the teeth by continuous gentle force for treatment of minor tooth malocclusion.