Catalog Number

980-00

Brand Name

ENVY Self Adhesive Resin Cement-A2 Shade

Version/Model Number

980-00

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 01, 2022

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

-

Product Code

EMA

Product Code Name

CEMENT, DENTAL

Public Device Record Key

2dc7ed85-b3f8-42c8-8574-fa3b9ba483e1

Public Version Date

October 19, 2022

Public Version Number

4

DI Record Publish Date

February 01, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-