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510(k) Data Aggregation
K Number
K250393Device Name
ZircaGlow & ZircaGlow HT Zirconia
Manufacturer
United Zirconia
Date Cleared
2025-05-12
(89 days)
Product Code
EIH
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
United Zirconia
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ZircaGlow & ZircaGlow HT Zirconia blanks are indicated for use by dental technicians for the production of full contour and substructures restorations up to a full arch.
Device Description
ZircaGlow & ZircaGlow HT Zirconia are disc and block 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 a crown, bridge or coping.
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