Invisalign Go Express

GUDID 00816063021377

Aligner

Align Technology, Inc.

Orthodontic progressive aligner
Primary Device ID00816063021377
NIH Device Record Keyee6e76f3-f290-44e8-879f-2b0b43b46893
Commercial Distribution StatusIn Commercial Distribution
Brand NameInvisalign Go Express
Version Model Number9033
Company DUNS013831768
Company NameAlign Technology, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100816063021377 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NXCAligner, Sequential

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-09-23
Device Publish Date2025-09-15

Devices Manufactured by Align Technology, Inc.

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