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510(k) Data Aggregation
K Number
K102207Device Name
FIBER FORCE
Manufacturer
Date Cleared
2010-11-23
(110 days)
Product Code
Regulation Number
872.3760Why did this record match?
Applicant Name (Manufacturer) :
SYNCA MARKETING, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
· As structural reinforcement for fabricating and/or repairing removable prostheses (dentures) and removable implant supported dentures (ISDs)
· As reinforcement for temporary and/or permanent plastic/composite partial and full crowns and bridges.
· As reinforcement for customized splints used to immobilize teeth which may be required for orthodontia, periodontia, traumatology and any dental activity requiring bonding of natural teeth.
Device Description
Fiber Force is a system of light-cured resin pre-impregnated E-glass fibers used for reinforcement in a variety of applications in dentistry. All formats of Fiber Force use specially treated E-glass fibers that impregnated in resin using an industrialized process that ensures homogeneity with the acrylic or composite resin interface material.
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K Number
K062237Device Name
CADI, VERSION 4
Manufacturer
Date Cleared
2006-11-20
(110 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
SYNCA MARKETING, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
CADI is a dental imaging software for general dental and maxillo-facial diagnostic. It controls capture, display, treatment, analysis and saving of digital images from x-ray units, intraoral or extraoral dental camera, digital cameras, and images acquired by digitizing film with a scanner, in order to enable a dentist to diagnose the dental health of a patient.
CADI is a prescription use only product, intended to be used by dental professionals only.
Device Description
CADI is a dental imaging software for general dental and maxillo-facial diagnostic. It controls capture, display, treatment, analysis and saving of digital images from x-ray units, intraoral or extraoral dental camera, digital cameras, and images acquired by digitizing film with a scanner. It is a modular software with the following modules: Digital x-ray module, Intraoral Camera Module, Digital Camera Module, Cosmetic and Whitening Module, Natural Smiles Library, and Orthocephalometric Tracing (DFO) Module.
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