Catalog Number

-

Brand Name

FluoriMax 2.5% NaF Varnish 12ML Bottle 5pk BG

Version/Model Number

630000501

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

K131376,K131376

Product Code

LBH

Product Code Name

Varnish, Cavity

Public Device Record Key

fecf0ffc-839e-443a-ac71-e4efd3383260

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

-