510(k) K182388
K182388 is an FDA 510(k) premarket notification submitted by Shatkin F.I.R.S.T., LLC for the device "Krystal Klear Aligners". The FDA issued a decision of Substantially Equivalent on Dec 19, 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 19, 2019
- Date Received
- Sep 4, 2018
- 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.