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K Number
K974486
Device Name
CLEARFIL LINER BOND 2V
Manufacturer
KURARAY AMERICA, INC.
Date Cleared
1998-01-29

(64 days)

Product Code
KLE
Regulation Number
872.3200
Type
Traditional
Panel
DE
Reference & Predicate Devices
K943170,K871636,K943165,K943167,K942493,K964525,K910860,K934690
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
  1. Direct filling restorations using light-cure or chemical-cure composite resin
  2. Bonded amalgam restorations
  3. Treatment of hypersensitive and/or exposed root surfaces
  4. Cavity sealing as a pretreatment for indirect restorations
  5. Intraoral repairs of facing crowns using light-cure composite resin
  6. Cementing laminate veneers, inlays and onlays made of porcelain (or composite resin) using composite resin cement
Device Description

CLEARFIL LINER BOND 2V is classified into the resin tooth bonding agent, CFR 21 Section 872.3200, because it is a device composed of materials such as dimethacrylate monomers intended to painted on the interior of a prepared cavity of a tooth to improve retention of restorative materials. PROTECT LINER F is classified into tooth shade resin material, CFR 21 Section 872.3690, because it is a device composed of material such as bisphenol A glycidylmethacrylate (Bis-GMA) intended to restore carious or structural defects in teeth. CLEARFIL PORCELAIN BOND ACTIVATOR was permitted to marketed under its 510 (k) notification submission.

This product is similar and substantially equivalent in design, composition and function to the similar products which are identified in the paragraph 4 of this summary; all of which are safe, effective and beneficial.

AI/ML Overview

The provided text is a 510(k) Pre-Market Notification for a dental adhesive system, CLEARFIL LINER BOND 2V. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials with acceptance criteria and detailed device performance outcomes against those criteria in the way a novel medical device might.

Therefore, the requested information categories (1-9) which are typically used to describe the acceptance criteria and study proving device performance for a novel device, are largely not applicable in the context of this 510(k) submission.

Here's an analysis of why and what information is available:

First, understanding the context:

  • 510(k) Submission: This is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective as, i.e., "substantially equivalent" to, a legally marketed predicate device. It does not require clinical trials to establish new safety and efficacy, but rather to show that the new device does not raise different questions of safety and effectiveness than the predicate device.
  • Predicate Device: CLEARFIL LINER BOND 2V is being compared to several predicate devices, with CLEARFIL LINER BOND 2 (K943170) being the primary one mentioned for technological improvement.

Let's address each point based on the provided text:

  1. A table of acceptance criteria and the reported device performance

    • Not Applicable in this context. For a 510(k), specific "acceptance criteria" for clinical performance (e.g., a certain sensitivity/specificity threshold) are generally not established in the same way as for a novel device requiring new efficacy data. Instead, the focus is on showing equivalence in composition, function, and intended use, often supported by bench testing and biocompatibility.
    • The document primarily describes a biocompatibility study for a new chemical ingredient (DMABB), not a clinical performance study against specific acceptance criteria.
    • Reported performance (Biocompatibility of DMABB):
      Test TypeAcceptance Criteria (Implied)Reported Device Performance
      Acute Toxicity (LD50)No significant toxicity at doses relevant to exposure.Not less than 4,000 mg/kg (Mouse, Oral, 10 days) - Negative
      GenotoxicityNo mutagenic effects.Negative (Ames test, 5 bacterial species, with/without S-9 mix)
      SensitizationNo evidence of allergic or hypersensitivity reactions.Negative (Maximization Sensitization Test)
      Leachables (DMABB)Amount leached should be below toxicologically relevant levels.Less than identification limit (0.04 ppm) in distilled water (at 37℃ and 50℃ for 24 hours)

  2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

    • Test Set Sample Size:
      • Acute Toxicity: Mouse (number not specified, but typically a group for dose-response).
      • Genotoxicity: Not applicable, as this is a laboratory test on bacterial cultures.
      • Sensitization: Not applicable, as this is a laboratory test, likely on animals (e.g., guinea pigs for maximization test), but the count is not specified.
      • Leachables: "Two pieces of cured resin" were used.
    • Data Provenance: Not explicitly stated, but assumed to be from internal Kuraray studies, likely conducted in Japan (the submitter's country). The studies are prospective in nature for these specific tests.

  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

    • Not Applicable. For biocompatibility and chemical leachable studies, ground truth is established through standardized laboratory methods (e.g., ISO standards, Ames test procedures, HPLC analysis) and observed biological responses, not an expert panel.

  4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

    • Not Applicable. Adjudication methods are relevant for subjective interpretations (e.g., image reading) or complex clinical endpoints. For the objective, quantitative lab tests described (LD50, genotoxicity, sensitization, leachable quantification), no adjudication method is used.

  5. 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 device is a dental adhesive, not an AI-powered diagnostic tool requiring human reader studies.

  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

    • Not Applicable. This device is a dental adhesive, not an algorithm.

  7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

    • Ground Truth for Biocompatibility/Chemical Tests:
      • Acute Toxicity: Live animal response (survival, clinical signs) to a chemical dose.
      • Genotoxicity: Presence/absence of mutations in bacterial strains, assessed against negative and positive controls.
      • Sensitization: Dermal reactions in test subjects/animals.
      • Leachables: Quantitative chemical analysis (High Pressure Liquid Chromatography - HPLC) for the presence and concentration of DMABB.

  8. The sample size for the training set

    • Not Applicable. No machine learning or AI is involved in this device, so there is no "training set."

  9. How the ground truth for the training set was established

    • Not Applicable. As no training set exists, this question is irrelevant.

Summary for this 510(k) Submission:

The provided document details a 510(k) submission, whose primary goal is to demonstrate substantial equivalence to existing predicate devices. Therefore, it focuses on comparing the new device's composition, intended use, and technological characteristics to those of legally marketed devices.

The "study that proves the device meets the acceptance criteria" in this context refers to biocompatibility testing conducted on a new chemical ingredient (DMABB) introduced in CLEARFIL LINER BOND 2V, which was not present in previously approved Kuraray products. These tests (acute toxicity, genotoxicity, sensitization, and leachable analysis) aim to show that this new ingredient does not pose new safety concerns, thereby supporting the overall substantial equivalence of the new device to its predicates. The "acceptance criteria" are generally implied by the negative results, indicating the absence of adverse toxicological effects or leachable levels above identification limits, consistent with standard biocompatibility assessments for medical devices.

§ 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.