Catalog Number

A350300V65

Brand Name

Creation Willi Geller

Version/Model Number

A350300V65

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

K010160

Product Code

ELM

Product Code Name

Denture, Plastic, Teeth

Public Device Record Key

c6567e8e-72dd-43ad-8eef-048043f5e8c3

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 06, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-