Catalog Number

000180

Brand Name

GC Fuji BOND™

Version/Model Number

000180

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

K953166,K953166

Product Code

KLE

Product Code Name

AGENT, TOOTH BONDING, RESIN

Public Device Record Key

45dc4457-1125-4db2-9c3c-8a21998d6170

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 01, 2016

Package DI Number

D0470001802

Quantity per Package

5

Contains DI Package

D0470001801

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton