Catalog Number

03720

Brand Name

Provi Bond, 25 ml

Version/Model Number

03720

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

K973201

Product Code

EMA

Product Code Name

Cement, Dental

Public Device Record Key

737b36e5-8cd5-4cb1-9f82-270395ad19b2

Public Version Date

June 29, 2020

Public Version Number

4

DI Record Publish Date

November 29, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-