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510(k) Data Aggregation
K Number
K063842Device Name
CYRTINA SYSTEM
Manufacturer
Date Cleared
2007-04-17
(112 days)
Product Code
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
ORATIO B.V.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Cyrtina system is intended for CAD/CAM fabrication of allceramic dental restorations. The system is used for the manufacturing of inlays, onlays, veneers, crowns and bridges.
Device Description
The CYRTINA SYSTEM is intended to fabricate all-ceramic dental devices like definite crowns and bridges. The Cyrtina System consists of two different materials: Cyrtina® BioZyram® is a core material made of zirconia. It is provided as green, shaded hexblocks especially developed for processing for milling at Cyrtina® Center. The five shades are combined with the grouped Cyrtina® Ceram shades. Sakura® Interaction is an all-ceramic overlay material in powder form developed for veneering Cyrtina® BioZyram® substructure by layering to provide esthetics and characterization for fixed prosthodontic devices that include both anterior and posterior crowns/bridges and for implant abutments. Sakura® Interaction consists of Liner/Dentin/Transparent/Incisal all-ceramic veneering material. The final restoration shade matches 16 Vita Lumen shades and four Bleach shades. Cyrtina® dental restorations are fabricated according to a dental impression which is scanned into a computing device. By CAD/CAM technology unfashioned zirconia blocks of Cyrtina® BioZyram® are milled in Cyrtina® Center. After the dental appliance has been milled the piece is sintered at a temperature of 1400°C. For esthetic reasons, the ceramic crown, bridge or abutment, resp. is veneered by Sakura® Interaction.
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