FDA.reportPublic FDA data

Align Technology, Inc.

Matched from indexed company URL: Align Technology, Ltd.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
29537493002519584Align Technology, Inc.1Y2026-01-012820 Orchard Parkway San Jose CA US 95134
30096469993009646999Align Technology, Ltd.1N2026-01-011 Yitzhak Rabin Rd. Petach Tikva Central IL 4925110
30252372433025237243Align Technology AFAB Poland Sp. z o.o.1N2026-01-01Bierutowska 44 Street Wroclaw Dolnoslaskie PL 51-317
30154628043015462804Align Technology de Costa Rica La Lima Center1N2020-04-25Calle 58, Zona Franca La Lima Edificio Corporative La Lima, Buil Guadalupe Cartago CR 30106

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2294261936654856K981095ALIGN SYSTEMNXC1998-09-08
555291936654856K981095ALIGN SYSTEMNXC1998-09-08
555291053736610K973776REFLECTIONSDYW1997-11-21
555291741912381K935625ALPHADENT LIGHT ACTIVATED ORTHODONTIC ADHESIVE BONDING SYSTEM WITH FLUORIDEDYH1994-08-10
555291703518202K252931Invisalign® Palatal Expander SystemNXC2025-10-23
555291088262779K252870Invisalign Specifix Attachment SystemNXC2025-10-09
555291359646703K252380Invisalign SystemNXC2025-08-29
3359351480700459K241412Invisalign SystemNXC2024-06-18
555291480700459K241412Invisalign SystemNXC2024-06-18
1417111797509223K240573iTero Lumina™ ProNTK2024-08-16
555291797509223K240573iTero Lumina™ ProNTK2024-08-16
555291845466246K232887Invisalign Palatal Expander SystemNXC2023-12-15
555291560695334K232233Invisalign System with Mandibular Advancement Featuring Occlusal BlocksNXC2023-09-26
555291354950530K222894Invisalign System, Pre-Formed Attachment SystemNXC2022-12-22
555291639802914K220287Invisalign SystemNXC2022-04-07
1417111885016593K193659iTero Element 5DNTK2020-03-20
555291885016593K193659iTero Element 5DNTK2020-03-20
555291759132342K181739Invisalign System with Mandibular Advancement FeatureNXC2018-10-26
2294261759132342K181739Invisalign System with Mandibular Advancement FeatureNXC2018-10-26
1417111543810240K131101ITERO SOFTWARENHA2013-08-26
555291585024134K082207ORTHOCAD IQDYW2009-10-23
1417111585024134K082207ORTHOCAD IQDYW2009-10-23
555291865829309K011419CAVEX COLORCHANGEELW2001-07-16
555291091686516
555291102423740
1417111191972145
555291400673304
555291417971431
1417111567511618
555291613510237
555291715633654
555291749306786
555291762931488
555291937173070
555292029671551
3359351085109229
555291085109229
3359351153969597
555291153969597
555291159053092
555291191972145
555291415314645
555291631774276
555291677354133
555291852532599
555292000126882
555292029770439

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NXC132025-10-23
NTK52024-08-16
DYW32009-10-23
NHA22013-08-26
ELW12001-07-16
DYH11994-08-10

PMN#

GUDID#

Invisalign™ Ultrasonic Cleaning Station - """The Invisalign Ultrasonic Cleaning Station is an over-the-counter electronic appliance that is intended to clean Invisalign® System clear aligner orthodontic appliances and Invisalign® and Vivera™ retainers using ultrasonic vibrations.The Invisalign™ Ultrasonic Cleaning Station is a countertop device that cleans Invisalign® clear aligners and Invisalign® and Vivera™ retainers by transmitting high-frequency sound waves (also called ‘ultrasonic’ vibrations) through a liquid medium, creating microscopic “scrubbing/ scouring” bubbles which dislodge debris as they collapse. The device offers a convenient way to clean these removable orthodontic appliances at home in as little as five minutes using just plain tap water and with no additional chemicals. In testing with water, the Invisalign Ultrasonic Cleaning Station removed 98.3% to 99.9% of the following odor-causing bacteria from Invisalign® clear aligners: Pseudomonas aeruginosa, Staphylococcus aureus, Klebsiella pneumoniae, Enterobacter cloacae and Escherichia coli. Performance of bacteria removal for retainers has not been evaluated."""

Align Technology, Inc.

2023-07-25

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