AccessGUDID - DEVICE: iTero Element 5D Plus Ready US Mobile configuration (00816063020813)

GUDID

Device Identifier (DI) Information

Brand Name: iTero Element 5D Plus Ready US Mobile configuration
Version or Model: 211899
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Align Technology, Inc.

Primary DI Number: 00816063020813
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 013831768 *Terms of Use

Device Description: Scanner, mobile configuration

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
38597	Dental milling system, CAD/CAM, chairside	An assembly of devices designed for automated computer-aided design (CAD) and computer-aided manufacturing (CAM) of custom-made (prescribed for one patient) dental restorations produced chairside during dental or orthodontic treatment. It typically includes, or is used in conjunction with, three-dimensional (3-D) image acquisition and viewing capabilities that provide values (measurements) for the production phase; software for record collection, treatment planning, simulation and device production; and robotic capabilities for the production of the actual devices to be fitted to the patient.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NTK	Caries Detector, Laser Light, Transmission

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K193659	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 80d431c9-5690-425b-8a5b-cc2d8b62beba
Public Version Date: April 04, 2023
Public Version Number: 4
DI Record Publish Date: June 04, 2021