iTero Lumina scanning unit

GUDID 00816063021599

Scanning unit (wand)

Align Technology, Inc.

Dental milling system, CAD/CAM, chairside
Primary Device ID00816063021599
NIH Device Record Keyc21c9fba-3854-498e-92ff-87afe682e6a1
Commercial Distribution StatusIn Commercial Distribution
Brand NameiTero Lumina scanning unit
Version Model Number214500
Company DUNS013831768
Company NameAlign Technology, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
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
GS100816063021599 [Primary]

FDA Product Code

NOFSystem, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-02-09
Device Publish Date2024-02-01

On-Brand Devices [iTero Lumina scanning unit]

00816063021599Scanning unit (wand)
00816063022138Scanning unit (wand)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.