510(k) K233356
K233356 is an FDA 510(k) premarket notification submitted by Laxmi Dental Export Pvt., Ltd. for the device "Illusion Aligner Pro: Illusion Aligner FLX". The FDA issued a decision of Substantially Equivalent on Aug 8, 2024. 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
- Aug 8, 2024
- Date Received
- Sep 29, 2023
- 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.