Catalog Number

678895

Brand Name

Aquasil Ultra DECA™ Smart Wetting® Impression Material

Version/Model Number

678895

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

41e4ed32-faa4-40b6-9862-926871b08991

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 21, 2016

Package DI Number

D00267889532

Quantity per Package

3

Contains DI Package

D0026788951

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case