Catalog Number

-

Brand Name

Vista-Cal 2 pack Foil Pouch

Version/Model Number

3627

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

K963922,K963922

Product Code

KIF

Product Code Name

Resin, Root Canal Filling

Public Device Record Key

56049088-346e-4769-a999-2222e83b33f7

Public Version Date

February 01, 2021

Public Version Number

2

DI Record Publish Date

August 28, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-