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510(k) Data Aggregation
K Number
K191304Device Name
EthanZir Zirconia
Manufacturer
Date Cleared
2019-11-04
(174 days)
Product Code
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
Besorah Dental Solutions NZ Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
EthanZirM Ziconia blanks are indicated for use in prosthetic dentistry to create porcelain (ceramic) prostheses (dentures. crowns and bridges). EthanZirM Zirconia blanks are intended to be milled and fully sintered by a Dental Professional or Dental Laboratory before use. Full contour monolithic crowns and bridges in anterior and posterior regions. Substructure ceramic for prostheses involving four or more units can be created.
Device Description
EthanZir™ Zirconia are disc shaped dental porcelain zirconia oxide blanks that come in various sizes that are used in custom restorations by the dental laboratory. The dental laboratory will further process the blank by milling the blank based upon the anatomically rendering of the patient's teeth (done at the dental office) through "Computer Aided Drafting/ Computer Aided Machining (CAD/CAM). Once the custom rendered blank is milled the product is fully sintered and colored (if required) and fitted to the patient's teeth as dentures, crowns or bridges.
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