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K Number
K172106
Device Name
SHOFU MZ Primer Plus
Manufacturer
Shofu Dental Corporation
Date Cleared
2017-08-31

(50 days)

Product Code
KLE,EMA
Regulation Number
872.3200
Type
Traditional
Panel
DE
Reference & 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.

§ 872.3200 Resin tooth bonding agent.

(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.