G-Premio™ BOND - G-Premio™ BOND 5mL Kit: 1 bottle 5mL, 50 - Gc America Inc.

Duns Number:005473608

Device Description: G-Premio™ BOND 5mL Kit: 1 bottle 5mL, 50 disposable applicators, 20 disposable trays

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More Product Details

Catalog Number

012691

Brand Name

G-Premio™ BOND

Version/Model Number

012691

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

K143140

Product Code Details

Product Code

KLE

Product Code Name

AGENT, TOOTH BONDING, RESIN

Device Record Status

Public Device Record Key

34b66287-51c9-4bdf-ad30-a9c518c953ac

Public Version Date

March 04, 2019

Public Version Number

1

DI Record Publish Date

February 01, 2019

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