Catalog Number

NA

Brand Name

DEXIS CariVu

Version/Model Number

1.010.5570

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K123402

Product Code

NTK

Product Code Name

Caries detector, laser light, transmission

Public Device Record Key

4e6c7f1c-69e5-49fa-81a4-4f52b32a8f16

Public Version Date

November 08, 2021

Public Version Number

7

DI Record Publish Date

September 26, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-