Catalog Number

000210

Brand Name

GC Fuji ORTHO™

Version/Model Number

000210

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K961417,K961417

Product Code

DYH

Product Code Name

ADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN

Public Device Record Key

87cfcf75-f3ac-468d-a318-8f6d825cc6d9

Public Version Date

August 29, 2022

Public Version Number

1

DI Record Publish Date

August 19, 2022

Package DI Number

24548161293683

Quantity per Package

5

Contains DI Package

14548161293686

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton