Catalog Number

245-2815

Brand Name

SCOTT'S SELECT 5% FLUORIDE VARNISH .40ml 50/bx MINT

Version/Model Number

245-2815

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)

-

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

1a5cb613-4d5f-4941-8873-b28fd168a89d

Public Version Date

February 07, 2019

Public Version Number

3

DI Record Publish Date

May 24, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-