Catalog Number

-

Brand Name

FluoriMax 2.5% NaF Varnish Flow Through

Version/Model Number

530CMV118

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,K131376

Product Code

LBH

Product Code Name

Varnish, Cavity

Public Device Record Key

c98db9b4-71b5-4d63-b8b4-501c92f1f37e

Public Version Date

February 07, 2019

Public Version Number

4

DI Record Publish Date

September 15, 2017

Package DI Number

00858290006239

Quantity per Package

70

Contains DI Package

00858290006222

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Kit