ENFORCE FRC™

Basic Information

• Brand Name: ENFORCE FRC™
• Primary DI: 10190886000533
• Version / Model: ENFORCE5
• Company Name: G & H Wire Company, Inc.
• Labeler DUNS: 831465641
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 4
• Public Version Date: 2023-01-31
• Public Version Status: Update
• Public Device Record Key: 8c1685f7-dd78-4e7c-a865-cfe21969e621
• Distribution End Date: 2017-09-14

Device Description

TRIAL 5CM 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 composite Easy-to-apply chairside method - no pre-adaptation Bonds chemically and mechanically Compatible with all bis-GMA cure composites Metal free & biocompatible Low profile and aesthetic Labial or lingual placement IDEAL FOR MANY APPLICATIONS: Lingual upper & lower retention Diastema retention Segmented treatment adjunct Trauma or periodontal splinting Extraction site maintenance Compliments TAD mechanics

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	872.3760	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44786	Dental reinforcing fibre	A device used in general restorative dentistry and orthodontic treatment typically as reinforcement of dental polymer-based materials, used for the construction of dental prostheses, i.e., splints, posts, crowns, and bridges. This device is typically made of polyethylene (PE) fibres supplied in strands, braid, or ribbon in a variety of sizes. It may also be used for the stabilization of avulsed teeth maintaining diastema closures or split-tooth syndrome. The ultrahigh molecular weight PE fibres increase the strength of composite materials, and provide improved safety by assisting in the retention of pieces in the event that a dental prosthesis is broken. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10190886000533	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K063170	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 36 – 46 Degrees Fahrenheit