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510(k) Data Aggregation
K Number
K120852Device Name
ZIRCONIA BLANKS (ZIRCOSTAR)
Manufacturer
Date Cleared
2012-06-06
(77 days)
Product Code
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
KEROX LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Zirconia Blanks are indicated for crowns, multi-unit bridges and inlay bridges. Applications include both anterior and posterior bridges.
Device Description
Zirconia Blanks are dental materials (semi finished products) made of presintered zirconium dioxide for milled production of crowns and bridges frameworks on commercial CAD/CAM systems or hand operated copymilling machines, with outstanding biocompatibility and high resistance against tension and pressure. In its pre-sintered condition the product is excellently suitable for preparing dental prostheses(crowns, bridges, superstructures, inlays and olays) produced by manual and machine milling technique.
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