Catalog Number

000554

Brand Name

GC METALPRIMER II

Version/Model Number

000554

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

K972594,K972594

Product Code

KLE

Product Code Name

AGENT, TOOTH BONDING, RESIN

Public Device Record Key

a4de0395-ce9a-408c-9751-7eb9e0e7476b

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 01, 2016

Package DI Number

D0470005542

Quantity per Package

5

Contains DI Package

D0470005541

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton