Catalog Number

-

Brand Name

PRO3DURE GR-17.1 temporary lt

Version/Model Number

500g - B2

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

K201827

Product Code

PZY

Product Code Name

Additively Manufactured, Preformed, Resin Denture Tooth

Public Device Record Key

740b9f09-6bc1-49f0-b40a-83d0db5fc88c

Public Version Date

November 26, 2020

Public Version Number

1

DI Record Publish Date

November 18, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-