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510(k) Data Aggregation
K Number
K193055Device Name
Purzir Dental Zirconia
Manufacturer
Date Cleared
2020-05-13
(194 days)
Product Code
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
3DBioCAD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Pürzir Dental Zirconia blanks are used for dental restorations using different CAD / CAM or manual milling machines. All blanks are processed through dental laboratories or by dental professionals.
Device Description
Pürzir Dental Zirconia are disc shaped zirconia oxide blanks made available in different versions and chemical compositions of various colors, shades and dimensions and sold to dental labs that will further process the discs by milling them to make final dental restorations such as crowns, bridges, veneers, inlays and on lays based on the anatomical rendering of the patient's teeth using Computer Aided Drafting / Computer Aided Machining (CAD / CAM) equipment. The subject device is made available in six versions: 1. HS (High Strength), 2. HT (High Translucent), 3. HT Plus (High Translucent Plus), 4. ST (Super Translucent), 5. MMT x2 (Max Multi Translucent), and 6. MMT Plus x2 (Max Multi Translucent Plus).
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