Itero Element

GUDID 00816063020134

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ALIGN TECHNOLOGY, INC.

Dental CAD/CAM system, chairside
Primary Device ID00816063020134
NIH Device Record Keydb9deef0-0247-41c5-ac41-44a50d45b35a
Commercial Distribution StatusIn Commercial Distribution
Brand NameItero Element
Version Model Number108063
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 Batchtrue
Serial Numbertrue
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
GS100816063020134 [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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-25
Device Publish Date2016-09-24

On-Brand Devices [Itero Element]

00816063020141Scanner
00816063020134Scanner

Trademark Results [Itero Element]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ITERO ELEMENT
ITERO ELEMENT
86977371 4838523 Live/Registered
Align Technology, Inc.
2014-06-06
ITERO ELEMENT
ITERO ELEMENT
86302950 5734120 Live/Registered
Align Technology, Inc.
2014-06-06

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