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510(k) Data Aggregation
K Number
K163228Device Name
APVolution System
Manufacturer
Date Cleared
2017-06-05
(200 days)
Product Code
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
AESTHETIC-PRESS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The APVolution System is used to fabricate prostheses for missing/damaged teeth. The APVolution pressable ingots are pressed onto metal alloy (APVolution M) or zirconia (APVolution Z) frames by dental technicians to fabricate ceramic restorations. APVolution M and APVolution Z ceramic layering powders and/or pastes are used to layer or build up the pressed ceramic to final tooth morphology. APVolution S ceramic ingots are used to create all-ceramic restorations. AP Stains and Glaze are used during the fabrication process to achieve the correct shade.
Device Description
The APVolution System consists of several silica glass ceramic materials used to create allceramic, ceramic-metal or ceramic-zirconia dental restorations. The APVolution System includes three ceramic ingots for use in the fabrication of all-ceramic (APVolution S), press-to-metal (APVolution M) or press-to-zirconia (APVolution Z) restorations. The system also includes powders and pastes for use in build-up and shaping of the final restoration, as well as shades and glazes for use in achieving acceptable aesthetics.
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