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510(k) Data Aggregation
K Number
K172106Device Name
SHOFU MZ Primer PlusManufacturer
Date Cleared
2017-08-31
(50 days)
Regulation Number
872.3200Type
TraditionalPanel
DentalReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Bonding resin to metal, zirconia or alumina restorations
- Application of opaque resin to frameworks
- Cementation of inlays, crowns and bridges with resin cement
- Bonding of denture base resin to metal base, clasp or attachment
- Bonding resin to orthodontic appliances
- Intraoral and extraoral repair of fractured restorations
Device Description
Not Found
AI/ML Overview
This document is an FDA 510(k) clearance letter for a dental bonding agent, SHOFU MZ Primer Plus. It declares the device substantially equivalent to legally marketed predicate devices.
The document does not contain information about acceptance criteria or a study proving device performance against acceptance criteria for an AI/CAD/software device. This is a clearance for a chemical dental product, not a software or AI-driven device.
Therefore, I cannot provide the requested information as it is not present in the provided text.
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