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510(k) Data Aggregation
K Number
K081537Device Name
CFS FLEXIBLE
Manufacturer
COMFORT AND FLEXIBLE SYSTEMS
Date Cleared
2009-01-22
(234 days)
Product Code
EBI
Regulation Number
872.3760Why did this record match?
Applicant Name (Manufacturer) :
COMFORT AND FLEXIBLE SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CFS FLEXIBLE™ is a break resistant material used in the fabrication and repair of base plates for removable dental prosthetic appliances where superior flexibility and patient comfort for the lifetime of the prosthetic are significant concerns. This includes, but not limited to, full and partial dentures, orthodontic devices, occlusal splints, and night guards.
Device Description
CFS FLEXIBLE™ is an injection moldable, flexible, thermoplastic nylon with trace amount of colorant added. CFS FLEXIBLE™ is used for fabricating removable dental prosthetic appliances such as in and 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.
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