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Adaptable Composite Resin Restorative Material is indicated for the following procedures:

1. Indications with tooth/restorative interface

• Class III and V restorations
• Conservative Class I restorations
• Small Class IV repairs
• Tunnel Preparations
• Filling of defects and undercuts in crown, inlay and onlay preparations
• Blockouts
• As a liner under direct restorative materials and under inlay restorations Class II box liner
• As a base or liner for cavity Class I and II restorations
• Repair of small enamel defects
• Covering incisal edge stains
• Pit and fissure Sealant

2. Indications including tooth/indirect restorative materials

• Cementing porcelain veneers, crowns, inlays/onlays
• Intraoral porcelain repair

3. Amalgam margin repair
4. Provisional or Indirect Laboratory Indications:

• Improving margins of acrylic temporaries
• Provisional occlusal changes
• Refacing acrylic temporaries
• Margin correction/adjustment of composite crowns for indirect laboratory use

The Adaptable Composite Resin Restorative Material is a one-component, fluoridecontaining, visible light cured, radiopaque resin composite restorative material.

Here's an analysis based on the provided document:

This document is a 510(k) summary for a dental device, specifically a "Adaptable Composite Resin Restorative Material." For such devices, acceptance criteria and the studies proving those criteria are typically related to biocompatibility and physical/chemical properties, rather than clinical efficacy studies often seen with diagnostic or interventional devices with quantitative performance metrics like sensitivity/specificity.

Acceptance Criteria and Device Performance

Study Details

Given the nature of the device (a restorative material), the studies performed are primarily non-clinical bench and biocompatibility tests. No study involving human subjects (like a diagnostic test dataset with ground truth) is described in this 510(k) summary. Therefore, many standard questions about clinical study design are not applicable here.

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

   • Test set for Biocompatibility: Not specified in the summary. These generally involve in-vitro (cell culture) and potentially in-vivo (animal) tests, but the number of samples or subjects is not disclosed.
   • Test set for In-vitro Bench Performance: Not specified in the summary. These tests typically involve multiple samples of the material for various physical and chemical property measurements.
   • Data Provenance: Not specified. It's an internal submission from DENTSPLY International, a US-based company, so tests are likely conducted in-house or by contract research organizations.

2. 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 material property testing, "ground truth" is established by adherence to recognized international standards (ISO series) and laboratory measurements of established parameters, rather than expert interpretation of a diagnostic output.

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

   • Not applicable. This is not a study involving human adjudication of results.

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 material, not a diagnostic or AI-assisted device.

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

   • Not applicable. This is a material, not an algorithm.

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

   • For biocompatibility: Ground truth is compliance with established biological response criteria defined by ISO 10993 and ISO 7405 standards.
   • For in-vitro bench tests: Ground truth is meeting or exceeding the specified physical and chemical property requirements defined by ISO 4049.

7. The sample size for the training set:

   • Not applicable. This device is not an AI/ML algorithm that requires a "training set." It is a material whose properties are developed and then verified.

8. How the ground truth for the training set was established:

   • Not applicable, for the reason above.

Summary of Study:

The "study" described in the 510(k) pertains to a series of non-clinical tests performed on the "Adaptable Composite Resin Restorative Material." These tests are categorized into two main areas:

1. Biocompatibility Tests: These were conducted in accordance with ISO 10993-1 (Biological Evaluation for Medical Device - Part 1: Evaluation and Testing) and ISO 7405 (Dentistry - preclinical evaluation of biocompatibility of medical devices used on dentistry - Test methods for dental materials). The results indicated that the material is biocompatible and safe for its intended use.
2. In-vitro Bench Tests: These tests assessed the physical and chemical properties of the material. The results demonstrated that the material "meets or exceeds the requirements of ISO 4049 (Dentistry - Polymer-based filling, restorative and luting materials) and safe for its intended use."

These tests collectively demonstrate that the device meets the necessary safety and performance standards for a dental restorative material, supporting its substantial equivalence to predicate devices.

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