CFS FLEXIBLE

GUDID D8422211061

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

CFS DENTAL INC

Dental appliance fabrication material, thermoplastic

• Primary Device ID: D8422211061
• NIH Device Record Key: 7ec9554b-1ef1-42a1-81cf-1c1968af3234
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CFS FLEXIBLE
• Version Model Number: 221106
• Company DUNS: 869564323
• Company Name: CFS DENTAL INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D8422211061 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081537

FDA Product Code

• EBI: Resin, Denture, Relining, Repairing, Rebasing

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-03-15