Catalog Number

-

Brand Name

iTero Element 5D upgrade, Kit US

Version/Model Number

209176

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)

-

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

76a84cd7-73b3-461d-a860-63b8b6049065

Public Version Date

February 21, 2022

Public Version Number

2

DI Record Publish Date

June 04, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-