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510(k) Data Aggregation
K Number
K062389Device Name
Z-BLOCK, MODELS 20/19, 40/19, 55/19
Manufacturer
Date Cleared
2006-08-21
(5 days)
Product Code
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
FOUNDATION MILLING CENTRE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This product is indicated for use as a substructure for Porcelain fused to ceramic fixed dental restorations; namely crowns and bridges. Foundation Milling Center Z-Blocks are machined using CAD/CAM technology.
Device Description
This product is a ceramic block made out of ZrO2 (Zirconia Oxide). There is a metal chuck glued on the end of the block that holds the block into the CAD/CAM machine. The block is milled into cores for teeth and then is fired in an oven to harden the ZrO2. Then the core is layered with ceramic porcelain to make a finished tooth.
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