Catalog Number

009553

Brand Name

G-Multi PRIMER

Version/Model Number

009553

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

K153231,K153231

Product Code

KLE

Product Code Name

AGENT, TOOTH BONDING, RESIN

Public Device Record Key

312f5149-ad94-407a-ac7a-457628591578

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 20, 2016

Package DI Number

D0470095534

Quantity per Package

60

Contains DI Package

D0470095531

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton