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510(k) K193659

Device
ITero Element 5D
Applicant
Align Technology, Inc.
510(k) number
K193659
Product code
NTK  
Decision
Substantially Equivalent (SESE)
Decision date
2020-03-20
Date received
2019-12-30
Regulation
872.1745
Classification name
Caries Detector, Laser Light, Transmission
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Angela M. Frederickson
Address
2820 Orchard Pkwy. San Jose CA US 95134 95134

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NTK  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K250771Primescan 2Dentsply Sirona, Inc.2025-08-29
K240573iTero Lumina™ ProAlign Technology , Ltd.2024-08-16
K213482TIA Tip, Cariosity, Transillumination Accessory TipD4D Technologies, LLC2022-04-29
K182712DEXIS CariVu 3-in-1 by KaVoKaltenbach & Voigt GmbH2019-11-23
K172007CamX Triton HD Proxi HeadDuerr Dental AG2017-11-22
K123402DIAGNOCAMKaltenbach & Voigt GmbH2013-09-24
K071429TI2200 TRANSILLUMINATION CABLEKerr Corporation2007-09-10
K062961MICROLUX TRANSILLUMINATORAddent, Inc.2007-02-08
K060080DIAGNODENT 2190 WITH PERIODONTAL PROBEKavo Dental Corporation2006-02-08
K043068DIFOTI USB 2.0 SYSTEMElectro-Optical Sciences, Inc.2004-12-29

Legacy Summary#

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FDA Review#

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