iTero Lumina Pro

GUDID 00816063023067

iTero Lumina Pro Software

Align Technology, Inc.

CAD/CAM software
Primary Device ID00816063023067
NIH Device Record Key3295bca2-bd27-47dc-ae1a-0f46951577c4
Commercial Distribution StatusIn Commercial Distribution
Brand NameiTero Lumina Pro
Version Model Number225979
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 Batchfalse
Serial Numberfalse
Manufacturing Datefalse
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
GS100816063023067 [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 Date2025-03-14
Device Publish Date2025-03-06

On-Brand Devices [iTero Lumina Pro]

00816063022664iTero Lumina Pro US Scanning Unit, RMA
00816063022657iTero Lumina Pro US Scanning Unit
00816063022213iTero Lumina Pro US Cart Configuration
00816063023067iTero Lumina Pro Software

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