Catalog Number

678897

Brand Name

Aquasil Ultra Rigid Super Fast Set DECA™ Smart Wetting@ Impression Material

Version/Model Number

678897

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

a7ccaa05-4629-45a6-8cc7-a2a6db5fcb1d

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 21, 2016

Package DI Number

D00267889732

Quantity per Package

3

Contains DI Package

D0026788971

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box