Catalog Number

770145

Brand Name

VELLA 5% Sodium Fluoride Varnish Case of 12 Boxes 35 Caramel

Version/Model Number

770145

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

K140350,K140350

Product Code

LBH

Product Code Name

Varnish, Cavity

Public Device Record Key

f04a0e90-6c0c-47e8-b939-e9c8fc99014a

Public Version Date

February 07, 2019

Public Version Number

4

DI Record Publish Date

September 28, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-