510(k) K193659
K193659 is an FDA 510(k) premarket notification submitted by Align Technology, Inc. for the device "iTero Element 5D". The FDA issued a decision of Substantially Equivalent on March 20, 2020. The device falls under product code NTK (Light Transmission Caries Detector), a Class II device regulated under 21 CFR 872.1745. Align Technology, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 20, 2020
- Date Received
- December 30, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Light Transmission Caries Detector
- Device Class
- Class II
- Regulation Number
- 872.1745
- Review Panel
- DE
- Submission Type