Align Technology L T D

FDA Filings

This page includes the latest FDA filings for Align Technology L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3009646999
FEI Number3009646999
NameAlign Technology, Ltd.
Owner & OperatorAlign Technology, Inc.
Contact Address2820 Orchard Parkway
San Jose CA 95134 US
Official Correspondent
  • Ryan D Hoffmeister
  • 1-408-7891588-1588
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address3 Ariel Sharon Boulevard
Or Yehuda Tel-Aviv, 6037606 IL
Establishment Type
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device

FDA Filings

Device
Company
DeviceDate
Align Technology, Ltd. [Align Technology, Inc.]
iTero Element 5D2020-03-24
Align Technology, Ltd. [Align Technology, Inc.]
iTero Software2016-06-24
Align Technology, Ltd. [Align Technology, Inc.]
iTero Software2016-06-24
Align Technology, Ltd. [Align Technology, Inc.]
iTero Articulator Kit2011-12-29
Align Technology, Ltd. [Align Technology, Inc.]
Cadent Articulator2011-12-29
Align Technology, Ltd. [Align Technology, Inc.]
Cadent Articulator Kit2011-12-29
Align Technology, Ltd. [Align Technology, Inc.]
iTero HDU Scanner2011-12-05
Align Technology, Ltd. [Align Technology, Inc.]
iTero HD2.9 Scanner2011-12-05
Align Technology, Ltd. [Align Technology, Inc.]
iTero Element2011-12-05
Align Technology, Ltd. [Align Technology, Inc.]
iTero Element Flex2011-12-05
Align Technology, Ltd. [Align Technology, Inc.]
iTero Element 22011-12-05
Align Technology, Ltd. [Align Technology, Inc.]
iOC Scanner2011-12-05

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