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K Number
K191524
Device Name
Visalys Tooth Primer
Manufacturer
Kettenbach GmbH & Co. KG
Date Cleared
2019-09-29

(111 days)

Product Code
KLE,DEV
Regulation Number
872.3200
Type
Traditional
Panel
DE
Reference & Predicate Devices
K150704
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

For permanent cementation of tooth structure to: · crowns, bridges, inlays, veneers and adhesive bridges in combination with Visalys® CemCore · root posts in combination with Visalys® CemCore and Visalys® Core · indirect core build-ups in combination with Visalys® CemCore For build-up adhesive bond to structure with Visalys® CemCore and Visalys® Core to fabricate: · adhesive core build-ups

Device Description

Visalys® Tooth Primer is a self-etching single-component primer with acidic polymers (10-MDP) for adhesive bonding of Visalys® CemCore and Visalys® Core to the dental hard substance. The primer can be applied without additional etching or after selective etching the enamel. Do not light cure Visalys® Tooth Primer. BPA or BPA precursors are not used in the manufacturing process of this device.

AI/ML Overview

This document is a 510(k) Premarket Notification for a dental device, Visalys® Tooth Primer. It is not a document describing an AI/ML medical device, and therefore does not contain the information requested in your prompt regarding acceptance criteria and performance studies for such a device.

The prompt asks for details specifically relevant to AI/ML device testing, such as:

  • Acceptance Criteria and Reported Performance Table: Not applicable here, as this device's performance is not measured in terms of AI metrics (e.g., sensitivity, specificity, AUC).
  • Sample Size and Data Provenance (Test Set): No test set in the context of AI/ML evaluation.
  • Number of Experts and Qualifications (Ground Truth): No expert-based ground truth establishment for a physical dental primer.
  • Adjudication Method: Not applicable.
  • MRMC Comparative Effectiveness Study: Devices like dental primers do not involve human readers assisted by AI.
  • Standalone Performance: Not applicable for a physical product.
  • Type of Ground Truth: Ground truth for a dental primer would be measured through physical/chemical properties and biocompatibility, not expert consensus or pathology in the AI sense.
  • Training Set Sample Size and Ground Truth Establishment: No training set for a physical device.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Panavia™ V5 Tooth Primer) based on:

  • Indications for Use (similar)
  • Technological Characteristics (similar)
  • Non-Clinical Performance Testing:
    • Shear Bond strength on enamel and dentin (according to ISO 29022). The document states the performance "satisfactorily met the requirements," implying it met certain thresholds, but it does not provide specific numerical acceptance criteria or reported values in a table format as requested for an AI device.
    • Biocompatibility tests (ISO 10993 family, ISO 7405) for cytotoxicity, mutagenicity, sensitization, and chemical analysis. The conclusion is "comparable or superior to the predicate device," but no specific numerical criteria or results are provided.
  • No Human Clinical Studies: The document explicitly states, "No data from human clinical studies has been included to support the substantial equivalence of Visalys® Tooth Primer."

Therefore, based on the provided text, it is not possible to fill out the requested information about acceptance criteria and study design for an AI/ML medical device. This document describes a traditional dental material, not an AI product.

§ 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.