GC Fuji ORTHO™ - Fuji Ortho Band LC Paste Pak SL - Gc America Inc.

Duns Number:005473608

Device Description: Fuji Ortho Band LC Paste Pak SL

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More Product Details

Catalog Number

013573

Brand Name

GC Fuji ORTHO™

Version/Model Number

013573

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

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

K073588

Product Code Details

Product Code

DYH

Product Code Name

ADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN

Device Record Status

Public Device Record Key

883a05a3-65cf-4316-b361-f09625317f1b

Public Version Date

December 22, 2021

Public Version Number

1

DI Record Publish Date

December 10, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GC AMERICA INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 480
2 A medical device with a moderate to high risk that requires special controls. 4772