ALIGN TECHNOLOGY, INC.

Address:2820 Orchard Parkway,San Jose,CA,95134,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Caries Detector, Laser Light, Transmission (NTK) (9) System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations (NOF) (4)

Premarket Exempt

No Yes

Clear

iTero Element 5D Plus US wand upgrade - 00816063020783 Catalog Number :

Device Description : Scanner, wand upgrade

Device Class : 2

Duns Number: 013831768

Premarket Exempt : No

Product Code : NTK

Prescription Use : Yes

Device Count : 1

iTero Element 5D Plus wand upgrade - 00816063020790 Catalog Number :

Device Description : Scanner, wand upgrade

Device Class : 2

Duns Number: 013831768

Premarket Exempt : No

Product Code : NTK

Prescription Use : Yes

Device Count : 1

iTero Element 5D Plus Ready US Cart configuration - 00816063020806 Catalog Number :

Device Description : Scanner, cart configuration

Device Class : 2

Duns Number: 013831768

Premarket Exempt : No

Product Code : NTK

Prescription Use : Yes

Device Count : 1

iTero Element 5D Plus Ready US Mobile configuration - 00816063020813 Catalog Number :

Device Description : Scanner, mobile configuration

Device Class : 2

Duns Number: 013831768

Premarket Exempt : No

Product Code : NTK

Prescription Use : Yes

Device Count : 1

iTero Wheel stand - 00816063020820 Catalog Number :

Device Description : Scanner wheel stand

Device Class : 2

Duns Number: 013831768

Premarket Exempt : No

Product Code : NOF, NTK

Prescription Use : Yes

Device Count : 1

iTero Computing Unit - 00816063020837 Catalog Number :

Device Description : Scanner computer unit

Device Class : 2

Duns Number: 013831768

Premarket Exempt : No

Product Code : NOF, NTK

Prescription Use : Yes

Device Count : 1

iTero Mobile Computing Unit - 00816063020844 Catalog Number :

Device Description : Scanner computer unit

Device Class : 2

Duns Number: 013831768

Premarket Exempt : No

Product Code : NOF, NTK

Prescription Use : Yes

Device Count : 1

iTero Element Scanning Unit - 00816063020851 Catalog Number :

Device Description : Scanning unit

Device Class : 2

Duns Number: 013831768

Premarket Exempt : Yes

Product Code : NOF

Prescription Use : Yes

Device Count : 1

iTero 5D Scanning Unit - 00816063020868 Catalog Number :

Device Description : Scanning unit

Device Class : 2

Duns Number: 013831768

Premarket Exempt : No

Product Code : NTK

Prescription Use : Yes

Device Count : 1

iTero 5D Scanning Unit - 00816063020875 Catalog Number :

Device Description : Scanning unit

Device Class : 2

Duns Number: 013831768

Premarket Exempt : No

Product Code : NTK

Prescription Use : Yes

Device Count : 1

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