Catalog Number

0079010FG

Brand Name

Silgimix® Alginate Replacement Impression Material

Version/Model Number

0079010FG

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

ELW

Product Code Name

MATERIAL, IMPRESSION

Public Device Record Key

8e707165-cd2d-4b96-97d8-78c753ffb43c

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 21, 2016

Package DI Number

D6870079010FG2

Quantity per Package

8

Contains DI Package

D6870079010FG0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case