Search Results
Found 3 results
510(k) Data Aggregation
K Number
K142894Device Name
TCS Blend
Manufacturer
Thermoplastic Comfort Systems, Inc.
Date Cleared
2015-02-03
(123 days)
Product Code
EBI
Regulation Number
872.3760Why did this record match?
Applicant Name (Manufacturer) :
Thermoplastic Comfort Systems, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
TCS Blend is a break resistant material used for the fabrication and repair of base plates for removable dental prosthetic appliances. This includes, but not to be limited to, partial or full removable dentures, orthodontic devices, occlusal splints and night guards.
Device Description
TCS Blend is an injection moldable, flexible, break-resistant thermoplastic resin provided with trace amounts of colorant added to produce shades of pink. The dental resin is packaged in individual use cartridges or in bulk.
TCS Blend is used for fabricating removable dental prosthetic appliances such as full and partial dentures, orthodontic devices, occlusal splints and night guards.
Ask a Question
K Number
K123396Device Name
I.FLEX BY TCS
Manufacturer
THERMOPLASTIC COMFORT SYSTEMS, INC.
Date Cleared
2013-01-10
(66 days)
Product Code
EBI, MQC
Regulation Number
872.3760Why did this record match?
Applicant Name (Manufacturer) :
THERMOPLASTIC COMFORT SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
i.flex by TCS is a thermoplastic resin used for the fabrication of partial or full removable dentures, as well as occlusal splints and night guards.
Device Description
i.flex by TCS is an injection moldable, flexible, thermoplastic resin provided with trace amounts of colorant added to produce shades of pink. The dental resin is packaged in individual use cartridges or in bulk. i.flex by TCS is used for fabricating removable dental prosthetic appliances such as full and partial dentures, occlusal splints and night guards.
Ask a Question
K Number
K053060Device Name
TCS UNBREAKABLE
Manufacturer
THERMOPLASTIC COMFORT SYSTEMS, INC.
Date Cleared
2006-07-20
(262 days)
Product Code
EBI
Regulation Number
872.3760Why did this record match?
Applicant Name (Manufacturer) :
THERMOPLASTIC COMFORT SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
TCS® Unbreakable is a break resistant material used in the fabrication and repair of base plates for removeable dental prosthetic appliances where superior flexibility and patient comfort for the lifetime of the prosthetic are significant concerns. This includes, but not to be limited to, full and partial dentures, orthodontic devices, occlusal splints, and night guards.
Device Description
Not Found
Ask a Question
Page 1 of 1