Catalog Number

772113

Brand Name

VELLAmini 5% Sodium Fluoride Varnish Bubble Gum Box 100

Version/Model Number

772113

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

1d1739d1-ab24-42f4-8201-8c50beca4ec9

Public Version Date

February 07, 2019

Public Version Number

4

DI Record Publish Date

October 05, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-