Catalog Number

-

Brand Name

Temporary Crown Matrix Buttons

Version/Model Number

100

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

Yes

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

EBG

Product Code Name

Crown And Bridge, Temporary, Resin

Public Device Record Key

4a83d6ee-82b0-4d1e-b5b8-900525ca3434

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 21, 2016

Package DI Number

10859787002052

Quantity per Package

24

Contains DI Package

00859787002055

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box