FDA 510(k), K193659, iTero Element 5D

510(K) Number: K193659
Device Name: iTero Element 5D
Manufacturer: Align Technology, Inc.
Device Classification Name: Caries Detector, Laser Light, Transmission
Regulation Number: 872.1745
Classification Product Code: NTK
Date Received: 12/30/2019
Decision Date: 03/20/2020
Regulation Medical Specialty: Dental

538 pages (3,174 of 3,712 original pages are fully redacted)