Catalog Number

1020054

Brand Name

Weropress Polymer C34

Version/Model Number

Weropress Polymer C34, 1000g

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K130076

Product Code

EBI

Product Code Name

Resin, Denture, Relining, Repairing, Rebasing

Public Device Record Key

000e8d82-a83d-4517-a56c-6b1d93a1e5cc

Public Version Date

August 09, 2022

Public Version Number

1

DI Record Publish Date

August 01, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-