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510(k) Data Aggregation
K Number
K190079Device Name
ArgenZ HT+Manufacturer
Date Cleared
2019-04-12
(86 days)
Product Code
Regulation Number
872.6660Type
TraditionalPanel
Dental Devices (DE)Why did this record match?
Device Name :
ArgenZ HT+
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
ArgenZ HT+ (high translucent plus) zirconia can be used for the production of full contour and substructures restorations up to a full arch.
Device Description
ArgenZ HT+ is a pressed Yttria stabilized Zirconia with primary oxides of Hafnium and Aluminum with naturally occurring trace oxides used to produce various shades.
AI/ML Overview
- Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from BS EN ISO 6872:2015 via predicate device or standard) | Reported Device Performance (ArgenZ HT+) |
|---|---|
| Flexural strength: ≥ 800 MPa | 1348 MPa (ArgenZ HT+ unshaded) |
| 1172 MPa (ArgenZ HT+ Shade A4) | |
| 1143 MPa (ArgenZ HT+ Shade OM1) | |
| Chemical solubility: |
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