GC Initial™ - GC Initial™ AL Entrance Kit, Liner - Gc America Inc.

Duns Number:005473608

Device Description: GC Initial™ AL Entrance Kit, Liner (A3/A3.5/A4/Cf), Dentin (DA3), Enamel (E-58, E-59), Ins GC Initial™ AL Entrance Kit, Liner (A3/A3.5/A4/Cf), Dentin (DA3), Enamel (E-58, E-59), Inside (IN-44), Clear Fluorescence (CL-F), Enamel Opal (EOP2), Glaze Powder & Liquid, Modeling Liquid

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

877037

Brand Name

GC Initial™

Version/Model Number

877037

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 01, 2016

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

K040567

Product Code Details

Product Code

EIH

Product Code Name

POWDER, PORCELAIN

Device Record Status

Public Device Record Key

ebd378dc-ff57-4b0e-bffb-6255c51696d8

Public Version Date

July 24, 2018

Public Version Number

4

DI Record Publish Date

August 01, 2016

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