510(k) K190394
K190394 is an FDA 510(k) premarket notification submitted by Sun Dental Laboratories, LLC for the device "SunClear Aligner system". The FDA issued a decision of Substantially Equivalent on Dec 16, 2019. 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
- Dec 16, 2019
- Date Received
- Feb 19, 2019
- 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
- 510(k)
The device moves the teeth by continuous gentle force for treatment of minor tooth malocclusion.