Catalog Number

339291

Brand Name

UNIFAST™

Version/Model Number

339291

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K984365,K984365

Product Code

EBG

Product Code Name

CROWN AND BRIDGE, TEMPORARY, RESIN

Public Device Record Key

cfd07405-2ddb-4525-855f-0c4f3bac8a86

Public Version Date

October 29, 2021

Public Version Number

4

DI Record Publish Date

August 01, 2016

Package DI Number

D6583392912

Quantity per Package

10

Contains DI Package

D6583392911

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton