BONDPRO™ AUTOMIX DUAL CURE BAND CEMENT 10gm SYRINGE - A unique dual cure composite resin cement ideally - G & H WIRE COMPANY, INC.

Duns Number:831465641

Device Description: A unique dual cure composite resin cement ideally suited for cementing metal molar bands. A unique dual cure composite resin cement ideally suited for cementing metal molar bands. Chemically bonds to both tooth structure and metal band to create a strong anchor. The glass ionomer technology creates high tensile and compressive strength, reducing washout and loose bands. The cement is ideally mixed and has no strong odor or aftertaste. The adhesive can be light cured to immediately set band in place. Without light activation, a complete set is achieved in five minutes. Contains fluoride for added tooth protection. Easily dispensed from economical screw syringes or in smart automix system.Single 10gm syringe (5gm catalyst & 5gm base).

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More Product Details

Catalog Number

-

Brand Name

BONDPRO™ AUTOMIX DUAL CURE BAND CEMENT 10gm SYRINGE

Version/Model Number

M977-01

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 01, 2017

Issuing Agency

In GS1

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

K981036

Product Code Details

Product Code

DYH

Product Code Name

Adhesive, Bracket And Tooth Conditioner, Resin

Device Record Status

Public Device Record Key

271501f5-4766-4eed-944c-bd3645d72680

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"G & H WIRE COMPANY, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3
2 A medical device with a moderate to high risk that requires special controls. 288