Catalog Number

-

Brand Name

iTero Element 5D Plus Ready US Mobile configuration

Version/Model Number

211899

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K193659

Product Code

NTK

Product Code Name

Caries Detector, Laser Light, Transmission

Public Device Record Key

80d431c9-5690-425b-8a5b-cc2d8b62beba

Public Version Date

February 21, 2022

Public Version Number

2

DI Record Publish Date

June 04, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-