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510(k) Data Aggregation
K Number
K161025Device Name
priti multidisc ZrO2 High Translucent
Manufacturer
PRITIDENTA GMBH
Date Cleared
2017-02-03
(297 days)
Product Code
EIH, CLA
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
PRITIDENTA GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
priti® multidisc ZrO2 High Translucent are pre-sintered zirconium oxide blanks for use in CNC (Computer Numerical Controls) milling machines to fabricate partial and single anterior and lateral crowns, bridges up to 3 units, inlays, onlays, and veneers for dental prostheses for restoration purposes only.
Device Description
The priti multidisc ZrOs High Translucent blanks are made of Yttria fully stabilized zirconia (5Y-FSZ Fully Stabilized Zirconia), whereby the increased translucency is due to the higher stabilization of the zirconia base powder with yttrium oxide (Y2O3).
The priti®multidisc ZrO₂ High Translucent blanks are provided as round discs with a diameter of 98.5mm, and varying thicknesses along with 16 VITA color shades, and multicolor versions.
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