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) (7) Resin, Denture, Relining, Repairing, Rebasing (EBI) (2) Applicator, Resin (KXR) (1)

Premarket Exempt

No Yes

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12 GM ETCH GEL WITH 25 TIPS - 10190886000519 Catalog Number :

Device Description : 12 GM ETCH GEL WITH 25 TIPS

Device Class : 2

Duns Number: 831465641

Premarket Exempt : No

Product Code : DYH

Prescription Use : Yes

Device Count : 1

ETCHANT SYRINGE TIPS FOR BSET15 - 10190886000526 Catalog Number : BSETIPS

Device Description : 25 replacement syringe tips for BSET15

Device Class :

Duns Number: 831465641

Premarket Exempt : Yes

Product Code : KXR

Prescription Use : Yes

Device Count : 25

ENFORCE FRC™ - 10190886000533 Catalog Number :

Device Description : TRIAL 5CMA revolutionary new concept in bonded lingual retention and periodontal TRIAL 5CMA revolutionary new concept in bonded lingual retention and periodontal splinting from G&H® Enforce frc™ incorporates thousands of glass fiber strands bundled together with a pre-impregnated light cure adhesive that allows adaptation directly in the patient's mouth.The intergrated fiber bundle is both malleable and tacky - perfect characteristics for close adaptation and positive retention prior to curing. .032" (.8mm) passive diameter - may be flattened significantly during adaption.The strength and durability of glass fibers combined with filled compositeEasy-to-apply chairside method - no pre-adaptationBonds chemically and mechanicallyCompatible with all bis-GMA cure compositesMetal free & biocompatibleLow profile and aestheticLabial or lingual placementIDEAL FOR MANY APPLICATIONS:Lingual upper & lower retentionDiastema retentionSegmented treatment adjunctTrauma or periodontal splintingExtraction site maintenanceCompliments TAD mechanics

Device Class : 2

Duns Number: 831465641

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

ENFORCE FRC™ - 10190886000540 Catalog Number :

Device Description : A revolutionary new concept in bonded lingual retention and periodontal splintin A revolutionary new concept in bonded lingual retention and periodontal splinting from G&H® Enforce frc™ incorporates thousands of glass fiber strands bundled together with a pre-impregnated light cure adhesive that allows adaptation directly in the patient's mouth.The intergrated fiber bundle is both malleable and tacky - perfect characteristics for close adaptation and positive retention prior to curing. .032" (.8mm) passive diameter - may be flattened significantly during adaption.The strength and durability of glass fibers combined with filled compositeEasy-to-apply chairside method - no pre-adaptationBonds chemically and mechanicallyCompatible with all bis-GMA cure compositesMetal free & biocompatibleLow profile and aestheticLabial or lingual placementIDEAL FOR MANY APPLICATIONS:Lingual upper & lower retentionDiastema retentionSegmented treatment adjunctTrauma or periodontal splintingExtraction site maintenanceCompliments TAD mechanics

Device Class : 2

Duns Number: 831465641

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

OCS GREEN 37% ETCH GEL 2OZ - 10190886000557 Catalog Number :

Device Description : 37% ETCH GEL 2OZ

Device Class : 2

Duns Number: 831465641

Premarket Exempt : No

Product Code : DYH

Prescription Use : Yes

Device Count : 1

OCS GREEN 37% ETCH LIQUID 2OZ - 10190886000564 Catalog Number :

Device Description : 37% ETCH LIQUID 2OZ

Device Class : 2

Duns Number: 831465641

Premarket Exempt : No

Product Code : DYH

Prescription Use : Yes

Device Count : 1

BONDPRO™ PORCELAIN ENHANCER 10cc - 10190886000571 Catalog Number :

Device Description : PORCELAIN ENHANCER 10cc. APPLIED PRIOR TO BONDING FOR STRONGER BONDS.

Device Class : 2

Duns Number: 831465641

Premarket Exempt : No

Product Code : DYH

Prescription Use : Yes

Device Count : 1

BONDPRO™ METAL ENHANCER 10cc - 10190886000588 Catalog Number :

Device Description : METAL ENHANCER 10cc. APPLIED PRIOR TO BONDING FOR STRONGER BONDS.

Device Class : 2

Duns Number: 831465641

Premarket Exempt : No

Product Code : DYH

Prescription Use : Yes

Device Count : 1

BONDPRO™ PLASTIC ENHANCER 10cc - 10190886000595 Catalog Number :

Device Description : PLASTIC ENHANCER 10cc. APPLIED PRIOR TO BONDING FOR STRONGER BONDS.

Device Class : 2

Duns Number: 831465641

Premarket Exempt : No

Product Code : DYH

Prescription Use : Yes

Device Count : 1

BONDPRO™ ONE STEP ADHESIVE KIT 1-5gm SYRINGE - 10190886000601 Catalog Number :

Device Description : One Step Adhesive intro kit. Contents: 1x5gm syringe, 3ml liquid etchant, 5ml p One Step Adhesive intro kit. Contents: 1x5gm syringe, 3ml liquid etchant, 5ml primer, instructions.

Device Class : 2

Duns Number: 831465641

Premarket Exempt : No

Product Code : DYH

Prescription Use : Yes

Device Count : 1

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