Catalog Number

Opaque (Universal Opaque) 8g

Brand Name

Dual Cure Resin Cement

Version/Model Number

Automix

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K201790

Product Code

EBF

Product Code Name

Material, Tooth Shade, Resin

Public Device Record Key

d72c3899-a608-4c65-abf7-0ca89bc28c23

Public Version Date

January 07, 2022

Public Version Number

1

DI Record Publish Date

December 30, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-