Catalog Number

73580

Brand Name

BISICO Provi Temp K A3.5 50ml

Version/Model Number

73580

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

K010012

Product Code

EBG

Product Code Name

Crown And Bridge, Temporary, Resin

Public Device Record Key

7dda1fd2-c9fb-40a7-9c40-97d38e9f1d22

Public Version Date

October 29, 2021

Public Version Number

6

DI Record Publish Date

January 18, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-