ENFORCE FRC™ - A revolutionary new concept in bonded lingual - G & H WIRE COMPANY, INC.

Duns Number:831465641

Device Description: A revolutionary new concept in bonded lingual retention and periodontal splinting from G&H 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

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More Product Details

Catalog Number

-

Brand Name

ENFORCE FRC™

Version/Model Number

ENFORCEKT

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

K063170

Product Code Details

Product Code

EBI

Product Code Name

Resin, Denture, Relining, Repairing, Rebasing

Device Record Status

Public Device Record Key

d9c9d6ac-95ef-4671-a808-d1649753997f

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