Catalog Number

34010

Brand Name

King Hue Anterior

Version/Model Number

34010

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

865b54ed-d927-4fc6-8bae-850c4bba7586

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

May 02, 2017

Package DI Number

17701126550249

Quantity per Package

20

Contains DI Package

07701126550242

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box