Catalog Number

950-10081

Brand Name

Health-Tec Clear Fluoride Varnish

Version/Model Number

950-10081

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

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

-

Product Code

LBH

Product Code Name

Varnish, Cavity

Public Device Record Key

270dc96f-36e8-4eb8-96c0-824ac455e454

Public Version Date

February 07, 2019

Public Version Number

3

DI Record Publish Date

January 24, 2017

Package DI Number

D773950100813C

Quantity per Package

12

Contains DI Package

D773950100812

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-