Invisalign System - Moderate 9001

GUDID 00816063020196

Sequential Aligners

ALIGN TECHNOLOGY, INC.

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Primary Device ID00816063020196
NIH Device Record Key719b738a-7a52-4722-b341-aec46662323a
Commercial Distribution StatusIn Commercial Distribution
Brand NameInvisalign System - Moderate
Version Model Number9001
Catalog Number9001
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100816063020196 [Primary]

FDA Product Code

NXCAligner, Sequential

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-04-24

Devices Manufactured by ALIGN TECHNOLOGY, INC.

00816063022138 - iTero Lumina Scanning Unit2024-02-23 Scanning unit (wand)
00816063021421 - iTero Lumina Cart upgrade from Element Plus2024-02-09 Upgrade kit for existing iTero users who upgrade their Plus scanner to Lumina scanner
00816063021438 - iTero Lumina Mobile Configuration2024-02-09 iTero Lumina Intraoral scanner Mobile Configuration
00816063021452 - iTero Lumina DOA Cart2024-02-09 Replacement package of iTero Lumina scanner in case of DOA
00816063021469 - iTero Lumina RMA Scanning Unit2024-02-09 Scanning unit (wand) replacement package
00816063021483 - iTero Lumina 25 Disposable Sleeves Box2024-02-09 Disposable single use sleeves box
00816063021599 - iTero Lumina scanning unit2024-02-09 Scanning unit (wand)
00816063021841 - iTero Lumina RMA, PPC Unit2024-02-09 Replacement package of cart computing unit - iTero Lumina

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