ITero Element 5D

Caries Detector, Laser Light, Transmission

Align Technology, Inc.

The following data is part of a premarket notification filed by Align Technology, Inc. with the FDA for Itero Element 5d.

Pre-market Notification Details

Device IDK193659
510k NumberK193659
Device Name:ITero Element 5D
ClassificationCaries Detector, Laser Light, Transmission
Applicant Align Technology, Inc. 2820 Orchard Parkway San Jose,  CA  95134
ContactAngela M. Frederickson
CorrespondentAngela Frederickson
Hogan Lovells US LLP 1601 Wewatta St #900 Denver,  CO  80202
Product CodeNTK  
CFR Regulation Number872.1745 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyDental
510k Review PanelDental
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-30
Decision Date2020-03-20

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