Catalog Number

1020

Brand Name

Universal Dentin Sealant

Version/Model Number

1020

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 05, 2018

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

K963979

Product Code

LBH

Product Code Name

VARNISH, CAVITY

Public Device Record Key

d1568512-8fc2-4bc6-ab39-4e77509c3488

Public Version Date

February 07, 2019

Public Version Number

5

DI Record Publish Date

September 22, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-