Catalog Number

CO2X4GUM

Brand Name

combo.lign GUM

Version/Model Number

CO2X4GUM

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

Product Code

EBF

Product Code Name

MATERIAL, TOOTH SHADE, RESIN

Public Device Record Key

63eab1ea-97b5-4264-aa70-5051a4b3f13a

Public Version Date

February 05, 2021

Public Version Number

3

DI Record Publish Date

September 20, 2016

Package DI Number

EBRECO2X4GUM9

Quantity per Package

1

Contains DI Package

EBRECO2X4GUM0

Package Discontinue Date

September 20, 2016

Package Status

Not in Commercial Distribution

Package Type

dummy