Catalog Number

-

Brand Name

Kenson

Version/Model Number

T1CB1U0X34

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

K924526

Product Code

ELM

Product Code Name

Denture, Plastic, Teeth

Public Device Record Key

0297bfc1-56c2-4390-b975-a52165a8ba4c

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

June 08, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-