iTero 5D Scanning Unit

GUDID 00816063020875

Scanning unit

ALIGN TECHNOLOGY, INC.

Dental CAD/CAM system, chairside
Primary Device ID00816063020875
NIH Device Record Keyf12f8efb-2991-4a5a-b36c-0b108deb031c
Commercial Distribution StatusIn Commercial Distribution
Brand NameiTero 5D Scanning Unit
Version Model Number211871
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
GS100816063020875 [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

On-Brand Devices [iTero 5D Scanning Unit]

00816063020875Scanning unit
00816063020868Scanning unit

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