G & H WIRE COMPANY, INC.

Address:40 Linville Way,Franklin,IN,46131,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Adhesive, Bracket And Tooth Conditioner, Resin (DYH) (10)

Premarket Exempt

No Yes

Clear

BONDPRO™ ONE STEP ADHESIVE KIT 4-5gm SYRINGES - 10190886000618 Catalog Number :

Device Description : One Step Adhesive Kit. Contents: 4x5gm syringe, 12ml primer, 7ml liquid etchant One Step Adhesive Kit. Contents: 4x5gm syringe, 12ml primer, 7ml liquid etchant, instructions, 50 sheet mixing pads, 30x 2" brushes, 2 mixing spatulas.

Device Class : 2

Duns Number: 831465641

Premarket Exempt : No

Product Code : DYH

Prescription Use : Yes

Device Count : 1

BONDPRO™ ONE STEP ADHESIVE SYR 5gm - 10190886000625 Catalog Number :

Device Description : 5gm adhesive syringe of composite resin for bonding plastic, metal or porcelain 5gm adhesive syringe of composite resin for bonding plastic, metal or porcelain orthodontic brackets to etched enamel.

Device Class : 2

Duns Number: 831465641

Premarket Exempt : No

Product Code : DYH

Prescription Use : Yes

Device Count : 1

BONDPRO™ LIQUID ETCHANT 7ml - 10190886000632 Catalog Number :

Device Description : 37% phosphoric acid liquid. 7ml.

Device Class : 2

Duns Number: 831465641

Premarket Exempt : No

Product Code : DYH

Prescription Use : Yes

Device Count : 1

BONDPRO™ GLASS IONOMER CEMENT POWDER/LIQUID KIT - 10190886000649 Catalog Number :

Device Description : An advanced formula designed as a multipurpose final cement for the cementation An advanced formula designed as a multipurpose final cement for the cementation of orthodontic bands. The cement is radio-opaque and has cariostatic properties by naturally releasing fluoride.Kit contents: 18gm powder, 17.5ml liquid, 50 sheet mixing pads, measuring scoop, instructions.

Device Class : 2

Duns Number: 831465641

Premarket Exempt : No

Product Code : DYH

Prescription Use : Yes

Device Count : 1

BONDPRO™ LIGHT ACTIVATED ADHES 1-5gm SYRINGE KIT - 10190886000656 Catalog Number :

Device Description : Intro Kit. A unique light activated composite resin system for bonding plastic, Intro Kit. A unique light activated composite resin system for bonding plastic, metal or porcelain orthodontic brackets to etched enamel.Kit contents: 1x 5gm syringe, 3ml liquid etchant, 3ml resin, instructions.

Device Class : 2

Duns Number: 831465641

Premarket Exempt : No

Product Code : DYH

Prescription Use : Yes

Device Count : 1

BONDPRO™ LIGHT ACTIVATED ADHESIVE 4-5gm SYRINGES - 10190886000663 Catalog Number :

Device Description : Full Kit. A unique light activated composite resin system for bonding plastic, Full Kit. A unique light activated composite resin system for bonding plastic, metal or porcelain orthodontic brackets to etched enamel.Kit contents: 4x 5gm syringes, 7ml liquid etchant, 7ml resin, 50 sheet mixing pads, 30x 2" brushes, 2x mixing spatulas, instructions.

Device Class : 2

Duns Number: 831465641

Premarket Exempt : No

Product Code : DYH

Prescription Use : Yes

Device Count : 1

BONDPRO™ LIGHT ACTIVATED ADHES 5gm SYRINGE - 10190886000670 Catalog Number :

Device Description : 1x 5gm adhesive syringe. A unique light activated composite resin system for bo 1x 5gm adhesive syringe. A unique light activated composite resin system for bonding plastic, metal or porcelain orthodontic brackets to etched enamel.

Device Class : 2

Duns Number: 831465641

Premarket Exempt : No

Product Code : DYH

Prescription Use : Yes

Device Count : 1

BONDPRO™ LIGHT ACTIVATED RESIN 7ml - 10190886000687 Catalog Number :

Device Description : 1x 7ml resin container. For use in the unique light activated BondPro™ composit 1x 7ml resin container. For use in the unique light activated BondPro™ composite resin system for bonding plastic, metal or porcelain orthodontic brackets to etched enamel.

Device Class : 2

Duns Number: 831465641

Premarket Exempt : No

Product Code : DYH

Prescription Use : Yes

Device Count : 1

BONDPRO™ AUTOMIX DUAL CURE BAND CEMENT INTRO KIT - 10190886000694 Catalog Number :

Device Description : Intro Kit. A unique dual cure composite resin cement ideally suited for cementi Intro Kit. 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.Kit contents: 1x 10gm syringe (5gm catalyst & 5gm base), 7 dispensing tips, instructions.

Device Class : 2

Duns Number: 831465641

Premarket Exempt : No

Product Code : DYH

Prescription Use : Yes

Device Count : 1

BONDPRO™ AUTOMIX DUAL CURE BAND CEMENT KIT - 10190886000700 Catalog Number :

Device Description : Full Kit. A unique dual cure composite resin cement ideally suited for cementin Full Kit. 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.Kit contents: 4x 10gm syringes (5gm catalyst & 5gm base), 50 sheet mixing pads, 30 dispensing tips, instructions.

Device Class : 2

Duns Number: 831465641

Premarket Exempt : No

Product Code : DYH

Prescription Use : Yes

Device Count : 1

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