Catalog Number

69010

Brand Name

Duratone-n Anterior

Version/Model Number

69010

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

ELM

Product Code Name

Denture, Plastic, Teeth

Public Device Record Key

10de72c1-8de0-44c3-9425-d4e8488b0ac3

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

February 27, 2017

Package DI Number

17701126550164

Quantity per Package

20

Contains DI Package

07701126550167

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX