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510(k) Data Aggregation
K Number
K150056Device Name
Luxisse+
Manufacturer
Date Cleared
2015-05-06
(114 days)
Product Code
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
HEANY INDUSTRIES INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Heany Industries, Inc. "Luxisse +" is non-implantable Zirconia material intended for CAD/CAM fabrication of all ceramic dental restorations. The material is used for the manufacturing of inlays, veneers, single unit anterior and posterior crowns, and three unit anterior bridges.
Device Description
Heany Industries Inc. "Luxisse +" is an all ceramic core dental material made of Yttria-Stabilized Zirconium Oxide (zirconia, YSZ). It is provided as a block or disk shape. CAD/CAM fabrication of core material can then be used to produce copings and substrates for fixed all ceramic dental restorations above the gum line. The material is used for the manufacturing of inlays, onlays, veneers, single unit posterior and anterior crowns, and three unit anterior bridges. The material is then fired in an oven to harden the ZrO2. The milling and final oven hardening is completed by the customer.
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K Number
K073314Device Name
HEANY INDUSTRIES INC DENTAL XIRCONIA
Manufacturer
Date Cleared
2008-02-21
(87 days)
Product Code
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
HEANY INDUSTRIES INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Heany Industries Inc. Dental Zirconia is non implantable material intended for CAD/CAM fabrication of core material used in all-ceramic dental restorations. The material is used for the manufacturing of inlays, veneers, crowns and bridges.
Device Description
Heany Industries Inc. Dental Zirconia is an all ceramic core material made of zirconium oxide. It is provided as a block or cisk shape. CAD/CAM fabrication of core matcrial can then be used to produce copings and or substrates for fixed all ceramic dental restorations above the gum line. The material is used for the manufacturing of inlays, onlays, veneers, crowns and bridges. The material is then fired in an oven to harden the ZrO2. The milling and final oven hardening is completed by the customer.
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