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510(k) Data Aggregation
K Number
K081749Device Name
AVANTE Z ZIRCONIA (AS)3 BLOCKS
Manufacturer
PENTRON CERAMICS, INC.
Date Cleared
2008-09-30
(103 days)
Product Code
EIH
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
PENTRON CERAMICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Avante Z Zirconia (AS) 3 Blocks consists of machinable zirconia blocks for the preparation of full ceramic crowns, onlays, and multi-unit bridges and inlay bridges (anterior and molar).
Device Description
Avante Z Zirconia (AS) Blocks are partially sintered yttriastabilized zirconia blocks for use as CAD/CAM milling blanks. They are in a chalk-like state and can be milled using anv compatible CAD/CAM machine such as Sirona InLab (Sirona Dental Systems, LLC. Charlotte, NC) or KaVO Everest (Ka Vo Dental, Lake Zurich, IL). It is necessary to mill the blocks with an enlargement factor to account for the shrinkage that occurs during sintering. After the block is milled, it is sintered which causes the material to densify into a high strength ceramic suitable for dental inllays, onlays, crowns, and bridges.
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K Number
K070699Device Name
AVANTE Z; PELLET, PRESSABLE STAIN, ADD-ON PORCELAIN, PORCELAIN
Manufacturer
PENTRON CERAMICS, INC.
Date Cleared
2007-06-29
(108 days)
Product Code
EIH
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
PENTRON CERAMICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Avante® Z is an all-ceramic dental restoration system used by a trained dental technician in a dental laboratory to create crowns (anterior and posterior), inlays, onlays, and veneers, with or without Zirconium Oxide (ZrO2) cores.
Device Description
Avante® Z is an all-ceramic dental restoration system
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