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K Number
K091705
Device Name
PRIMER PLUS
Manufacturer
BISCO, INC.
Date Cleared
2009-08-28

(79 days)

Product Code
KLE,CLA
Regulation Number
872.3200
Type
Traditional
Panel
DE
Reference & Predicate Devices
K061906,K011159
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Primer Plus is a universal restoration primer.

The principle uses of the Primer Plus are:

    1. Indirect restorations (such as composite, endodontic posts, metal/metal alloys, porcelain, zirconia, alumina, ceramics, and hybrid ceramics)
    1. Intraoral repairs of fractured crowns and bridges (such as metals/metal alloys, porcelain, zirconia, alumina, ceramics, hybrid ceramics, or composite resin)
Device Description

The Primer Plus is a universal restoration primer.

AI/ML Overview

The provided text is for a 510(k) summary for a dental product called "Primer Plus Universal Restoration Primer" by Bisco, Inc. This document does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML medical device.

The document is a regulatory submission for a dental material, not an AI/ML diagnostic or assistive device. Therefore, the concepts of "acceptance criteria," "test set," "ground truth," "MRMC study," "standalone performance," and "training set" as they relate to AI/ML device performance are not applicable to this submission.

The document discusses:

  • Description of the Device: "Primer Plus is a universal restoration primer."
  • Intended Use: Indirect restorations and intraoral repairs of fractured crowns and bridges.
  • Substantial Equivalence: The device is being cleared based on its substantial equivalence to legally marketed predicate devices (Clearfil Ceramic Primer (K061906) and One Step Plus (K011159)) in terms of intended use, indications for use, chemical composition, and physical properties.
  • Biocompatibility: An evaluation of biocompatibility was conducted to determine safety.

In a traditional medical device 510(k) submission like this, "acceptance criteria" would refer to the performance benchmarks demonstrated by the predicate device that the new device must meet or exceed to prove substantial equivalence. The "study" mentioned would typically involve material property testing (e.g., bond strength, mechanical properties, biocompatibility) to show that the new device performs comparably to the predicates.

However, none of the specific AI/ML-related questions you asked can be answered from this document.

§ 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.