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510(k) Data Aggregation
K Number
K131117Device Name
ZIRMON SERIES
Manufacturer
KUWOTECH CO., LTD
Date Cleared
2013-07-26
(95 days)
Product Code
EIH, ELL
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
KUWOTECH CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Zirmon Series is indicated for use as a substructure for porcelain fused ceramic fixed dental restorations; namely crown, bridges, inlays, and onlays.
Device Description
The Zirmon Series is zirconia-based ceram provided in shapes of square and circle used to manufacture cores of all ceramic crowns, and is classified into ISO6872 Type 2 Class 1. This dental porcelain for cutting process is provided by shaping and semi-sintering zirconia powder and is used to manufacture ceramic restoration with cutting process by dental MAD/MAM, computer-assisted design system, or manufacturing units, CAD/CAM system.
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