Catalog Number

-

Brand Name

Good Fit Instant Denture Setups

Version/Model Number

817610025602

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

EKO

Product Code Name

Denture Preformed (Partially Prefabricated Denture)

Public Device Record Key

6a4a424d-e648-4d03-b27a-e6f3a6d1bcc7

Public Version Date

December 25, 2019

Public Version Number

1

DI Record Publish Date

December 17, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-