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) (5) System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations (NOF) (5)

Premarket Exempt

No Yes

Clear

iTero Element Plus wheel stand, service - 00816063020981 Catalog Number :

Device Description : WS service

Device Class : 2

Duns Number: 013831768

Premarket Exempt : Yes

Product Code : NOF

Prescription Use : Yes

Device Count : 1

Packed Element Plus Scanning Unit, RMA - 00816063020998 Catalog Number :

Device Description : Wand RMAs

Device Class : 2

Duns Number: 013831768

Premarket Exempt : Yes

Product Code : NOF

Prescription Use : Yes

Device Count : 1

Packed 5D Plus Scanning Unit, RMA - 00816063021001 Catalog Number :

Device Description : Packed 5D Plus Scanning Unit, RMA

Device Class : 2

Duns Number: 013831768

Premarket Exempt : No

Product Code : NTK

Prescription Use : Yes

Device Count : 1

Packed 5D Plus US Scanning Unit, RMA - 00816063021018 Catalog Number :

Device Description : Wand RMAs

Device Class : 2

Duns Number: 013831768

Premarket Exempt : No

Product Code : NTK

Prescription Use : Yes

Device Count : 1

Packed 5D Plus Lite Scanning Unit, RMA - 00816063021025 Catalog Number :

Device Description : Wand RMAs

Device Class : 2

Duns Number: 013831768

Premarket Exempt : No

Product Code : NTK

Prescription Use : Yes

Device Count : 1

Packed iTero Computing Unit RMA E2 Plus - 00816063021032 Catalog Number :

Device Description : PPC RMAs

Device Class : 2

Duns Number: 013831768

Premarket Exempt : Yes

Product Code : NOF

Prescription Use : Yes

Device Count : 1

Packed iTero Computing Unit RMA 5D Plus - 00816063021049 Catalog Number :

Device Description : PPC RMAs

Device Class : 2

Duns Number: 013831768

Premarket Exempt : No

Product Code : NTK

Prescription Use : Yes

Device Count : 1

Packed iTero Mobile Computing Unit RMA E2 Plus - 00816063021056 Catalog Number :

Device Description : PPC RMAs

Device Class : 2

Duns Number: 013831768

Premarket Exempt : Yes

Product Code : NOF

Prescription Use : Yes

Device Count : 1

Packed iTero Mobile Computing Unit RMA 5D Plus - 00816063021063 Catalog Number :

Device Description : PPC RMAs

Device Class : 2

Duns Number: 013831768

Premarket Exempt : No

Product Code : NTK

Prescription Use : Yes

Device Count : 1

DOA Kit, Element 2 Plus - 00816063021070 Catalog Number :

Device Description : DOA Kits

Device Class : 2

Duns Number: 013831768

Premarket Exempt : Yes

Product Code : NOF

Prescription Use : Yes

Device Count : 1

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