Catalog Number

3303001

Brand Name

Axcent Acrylics

Version/Model Number

3303001

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

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

EBH

Product Code Name

Material, Impression Tray, Resin

Public Device Record Key

464f1c05-33ce-4b26-a4ab-bfb49661df1f

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 25, 2016

Package DI Number

D79333030011

Quantity per Package

4

Contains DI Package

D79333030010

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-