CFS FLEXIBLE

Basic Information

• Brand Name: CFS FLEXIBLE
• Primary DI: D8422211061
• Version / Model: 221106
• Company Name: CFS DENTAL INC
• Labeler DUNS: 869564323
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-03-15
• Public Version: 4
• Public Version Date: 2022-12-12
• Public Version Status: Update
• Public Device Record Key: 7ec9554b-1ef1-42a1-81cf-1c1968af3234

Device Description

CFS FLEXIBLE is an injection foldable, flexible, thermoplastic nylon with trace amounts of colorant added. CFS FLEXIBLE is used for fabricating removable dental prosthetic appliances such as partial dentures, orthodontics devices, occlusal splints, and night guards both permanent and temporary. Because it can be used to create completely non metallic prosthetics, it is perfect for making removable dental prosthetic appliances for metal allergic patients

Device Characteristics

• Single Use: Yes
• 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: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• 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
58288	Dental appliance fabrication material, thermoplastic	A thermoplastic material intended to be used in the dental laboratory to manufacture a patient-worn dental appliance (e.g., denture/denture base, orthodontic retainer, implant bars, crowns/bridges, occlusal splint, mouthguard); it might in addition be intended to fabricate non-patient worn devices (e.g., dental impression tray). The material [e.g., nylon 12 beads, polyetheretherketone (PEEK) milling blank, thermoplastic sheet] is manipulated [e.g., by melting and moulding, or computer-aided techniques (dental CAD/CAM)] to form the shape needed for the patient. After application, this material cannot be refabricated.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D8422211061	HIBCC