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510(k) Data Aggregation
K Number
K140070Device Name
LUXER SHADED ZIRCONIA
Manufacturer
CONTINENTAL DENTAL CERAMICS, INC.
Date Cleared
2014-05-07
(114 days)
Product Code
EIH
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
CONTINENTAL DENTAL CERAMICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Luxer Shaded Zirconia blanks/discs are intended for use with CAD/CAM technology to produce all-ceramic dental restorations (full contour crowns and bridges) as prescribed by a dentist.
Device Description
Luxer Shaded Zirconia blanks are pressed and sintered blocks of Yttria stabilized Zirconia for use in CAD/CAM milling machines. It comes in different thicknesses (12 mm - 20 mm) and classic VITA shades A-D. In order to achieve pigmentation, four basic color components are used from the TOSOH TZ-Series of zirconia {white, yellow, pink, and gray} that yield corresponding VITA shades (A-D). After the Zirconia block is milled, it is sintered into a high strength all ceramic material suitable for full contour crowns and bridges. The material is biocompatible, has a high flexural strength (>1100 Mpa), and is water insoluble. These characteristics meet the ISO standard 6872 for an esthetic dental ceramic material.
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K Number
K122972Device Name
CDC ZIRCONIA BLANKS
Manufacturer
CONTINENTAL DENTAL CERAMICS, INC. (DBA CONTINENTAL
Date Cleared
2012-10-24
(28 days)
Product Code
EIH, CLA
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
CONTINENTAL DENTAL CERAMICS, INC. (DBA CONTINENTAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CDC Zirconia Blanks are intended for use with CAD/CAM technology to produce all-ceramic dental restorations (copings, frameworks, inlays, onlays, crowns and bridges) as prescribed by a dentist.
This product is for professional use only. Not for use by the general public or OTC.
Device Description
CDC Zirconia blanks are pressed and sintered blocks of Yttria stabilized Zirconia for use in CAD/CAM milling machines. After the Zirconia block is milled, it is sintered into a high strength all ceramic material suitable for copings, inlays, crowns, and bridges.
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