Catalog Number

1215894

Brand Name

Dual Form V Anterior

Version/Model Number

1215894

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

ae4c7bba-cc26-4008-9ce0-dd635f0ad325

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 24, 2016

Package DI Number

10304040000943

Quantity per Package

20

Contains DI Package

00304040000946

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX