iTero Element 5D Plus Ready US Mobile configuration

GUDID 00816063020813

Scanner, mobile configuration

ALIGN TECHNOLOGY, INC.

Dental CAD/CAM system, chairside
Primary Device ID00816063020813
NIH Device Record Key80d431c9-5690-425b-8a5b-cc2d8b62beba
Commercial Distribution StatusIn Commercial Distribution
Brand NameiTero Element 5D Plus Ready US Mobile configuration
Version Model Number211899
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 Numbertrue
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
GS100816063020813 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NTKCaries Detector, Laser Light, Transmission

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-06-14
Device Publish Date2021-06-04

Devices Manufactured by ALIGN TECHNOLOGY, INC.

00816063022091 - Invisalign System with Mandibular Advancement Featuring Occlusal Blocks (MAOB)2024-05-24 Invisalign System with Mandibular Advancement Featuring Occlusal Blocks (MAOB) is used to introduce mandibular skeletal changes
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)

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