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K Number
K032455
Device Name
PANAVIA F 2.0
Manufacturer
KURARAY MEDICAL INC.
Date Cleared
2003-11-07

(88 days)

Product Code
EMA
Regulation Number
872.3275
Type
Traditional
Panel
DE
Reference & Predicate Devices
K012441,K012432,K012442
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

PANAVIA F 2.0 is indicated for the following applications:

  • Cementation of metal crowns and bridges, inlays and onlays. 1)
    1. Cementation of porcelain crowns, inlays, onlays and veneers.
    1. Cementation of composite resin crowns, inlays and onlays
  • Cementation of adhesion bridges 4)
    1. Cementation of endodontic cores and prefabricated posts
    1. Amalgam bonding
Device Description

PANAVIA F 2.0 is classified into dental cement, CFR 21 Section 872.3275, because it is a device composed of materials such as dimethacrylate monomers and inorganic fillers intended to be used for cementation of dental devices such as crown and bridges.

AI/ML Overview

The provided text is a 510(k) summary for a dental cement (PANAVIA F 2.0). It focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and safety, rather than providing a study demonstrating performance against specific acceptance criteria like a medical imaging AI device would.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, AI improvement effect size, standalone performance) are not applicable to this type of device and submission.

However, I can extract information related to product specifications and testing that can be interpreted as demonstrating "acceptance criteria" even if not explicitly labeled as such in the text.

Here's a breakdown of the available information:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria/CharacteristicReported Device Performance (PANAVIA F 2.0)
Material CompositionIngredients are the same as predicate devices (PANAVIA F and CLEARFIL SE BOND).
Intended UsesSame as predicate device (PANAVIA F - K012441): cementation of metal, porcelain, and composite resin crowns, bridges, inlays, onlays, veneers, adhesion bridges, endodontic cores, prefabricated posts, and amalgam bonding.
Compliance StandardComplies with ISO 4049:2000.
Light Curing TimesAssigned according to the type of dental curing lights.
Depth of CureMeasured, stated as "superior to PANAVIA F."
Thickness of Surface Unpolymerized LayerMeasured, stated as "superior to PANAVIA F."
Sensitivity to Ambient LightMeasured, stated as "superior to PANAVIA F."
SafetyIngredients are the same as predicate devices, thus safety is "substantially equivalent."

Study Information (where applicable)

  1. Sample size used for the test set and the data provenance: Not explicitly stated as a "test set" in the context of performance metrics for an AI/diagnostic device. The submission refers to measurement of properties. The provenance of the data (e.g., country of origin, retrospective/prospective) is not specified.

  2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for diagnostic devices (e.g., expert consensus on image findings) is not relevant for this material science submission. Performance is based on physical and chemical properties measured in a lab.

  3. Adjudication method for the test set: Not applicable. Performance is based on direct measurements of material properties, not subjective assessment requiring adjudication.

  4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a dental cement, not a diagnostic AI device.

  5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a dental cement.

  6. The type of ground truth used: For physical and chemical properties (depth of cure, unpolymerized layer thickness, ambient light sensitivity), the "ground truth" would be the direct, quantitative measurements obtained via laboratory testing following ISO standards (specifically ISO 4049:2000). For safety and composition, the "ground truth" is the established safety profile of the identical ingredients used in predicate devices.

  7. The sample size for the training set: Not applicable. There is no concept of a "training set" for this type of material science submission.

  8. How the ground truth for the training set was established: Not applicable.

§ 872.3275 Dental cement.

(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.