Catalog Number

8670900

Brand Name

RIVA SILVER

Version/Model Number

RIVA SILVER LQD REF 10G

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 07, 2016

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

K042452

Product Code

EMA

Product Code Name

CEMENT, DENTAL

Public Device Record Key

ea0a2a35-210c-4b83-9dae-1b1e58b9b92e

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 07, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-