Catalog Number

-

Brand Name

FluoriMax 2.5% NaF Varnish Through

Version/Model Number

530MTV110

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

Yes

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

K131376

Product Code

LBH

Product Code Name

Varnish, Cavity

Public Device Record Key

8b60499c-ce20-4c19-b63c-f497fdea2dbc

Public Version Date

February 07, 2019

Public Version Number

4

DI Record Publish Date

May 10, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-