GC Initial™ - GC Initial™ MC Classic Line Welcome Set, Paste - Gc America Inc.

Duns Number:005473608

Device Description: GC Initial™ MC Classic Line Welcome Set, Paste opaque classic line (PO-CL A3), 4g, dentin GC Initial™ MC Classic Line Welcome Set, Paste opaque classic line (PO-CL A3), 4g, dentin D-13 20g, Enamel E-59, 20g, modeling liquid 25mL, Invivo/Insitu Glaze liquid 25mL, Invivo/Insitu Glaze powder GL 10g, GC Initial Inmetalbond 4g

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More Product Details

Catalog Number

877082

Brand Name

GC Initial™

Version/Model Number

877082

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

K040567

Product Code Details

Product Code

EIH

Product Code Name

POWDER, PORCELAIN

Device Record Status

Public Device Record Key

7b15164b-ea9d-4891-b5b7-4405e6bcaa6b

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