ALIGN TECHNOLOGY, INC.

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

Aligner, Sequential (NXC) (8) Bracket, Plastic, Orthodontic (DYW) (1) Maintainer, Space Preformed, Orthodontic (DYT) (1)

Premarket Exempt

No Yes

Clear

Invisalign Full - 00816063020004 Catalog Number : 8500

Device Description : Sequential Aligners

Device Class : 2

Duns Number: 013831768

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

Invisalign - 00816063020011 Catalog Number :

Device Description : Retainer

Device Class : 2

Duns Number: 013831768

Premarket Exempt : Yes

Product Code : DYW

Prescription Use : Yes

Device Count : 1

Vivera - 00816063020028 Catalog Number :

Device Description : Retainer

Device Class : 1

Duns Number: 013831768

Premarket Exempt : Yes

Product Code : DYT

Prescription Use : Yes

Device Count : 1

Invisalign Teen - 00816063020035 Catalog Number : 8506

Device Description : Aligner

Device Class : 2

Duns Number: 013831768

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

Invisalign Express 10 - 00816063020042 Catalog Number :

Device Description : Aligner

Device Class : 2

Duns Number: 013831768

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

Invisalign Express 5 - 00816063020059 Catalog Number :

Device Description : Aligner

Device Class : 2

Duns Number: 013831768

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

Invisalign Lite - 00816063020066 Catalog Number :

Device Description : Aligner

Device Class : 2

Duns Number: 013831768

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

Invisalign i7 - 00816063020073 Catalog Number :

Device Description : Aligner

Device Class : 2

Duns Number: 013831768

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

Invisalign Assist - 00816063020080 Catalog Number :

Device Description : Aligner

Device Class : 2

Duns Number: 013831768

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

Realine - 00816063020097 Catalog Number :

Device Description : Aligner

Device Class : 2

Duns Number: 013831768

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

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