FDA.reportPublic FDA data

Align Technology, Ltd.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30096469993009646999Align Technology, Ltd.1N2026-01-011 Yitzhak Rabin Rd. Petach Tikva Central IL 4925110

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1417111258235452K261847iTero Lumina™ ProNTK2026-07-02
1417111797509223K240573iTero Lumina™ ProNTK2024-08-16
1417111885016593K193659iTero Element 5DNTK2020-03-20
1417111543810240K131101ITERO SOFTWARENHA2013-08-26
1417111585024134K082207ORTHOCAD IQDYW2009-10-23
1417111191972145
1417111567511618

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NTK42026-07-02
NHA22013-08-26
DYW12009-10-23