(98 days)
The Nanocomposite Restorative Kit consists of 2 types of nanocomposite restorative materials with a compatible bonding agent. The specific indications of each kit component are as follows:
- Nanocomposite is indicated for:
- Restorations of all cavity classes
- Fabrication of direct inlays, onlays and indirect veneers
- Core build-up after tooth preparation with the root canal post
- Machinable Composite for Restorations
- Indirect Inlays/Onlays
- Nanocomposite Flowable is indicated for:
- Small fillings of cavity classes III, IV and V
- Minimally invasive fillings for deciduous teeth (all cavity classes)
- Splinting of teeth
- MDP One Bottle Bond is indicated for:
- Bonding resin-based materials (especially light-cure composite / compomer materials) to tooth structure (dentin and enamel)
The Nanocomposite Restorative Kit consists of 3 materials: Nanocomposite, Nanocomposite Flowable, and MDP One Bottle Bond.
Here's an analysis of the provided text, focusing on acceptance criteria and supporting studies.
Based on the provided 510(k) summary, there is no detailed information regarding specific acceptance criteria, study designs, or reported device performance metrics in the way one would expect for a typical medical device performance study.
This 510(k) is an Abbreviated 510(k), which means the manufacturer is relying on conformity with recognized FDA guidance documents and demonstrating substantial equivalence to predicate devices rather than conducting extensive new clinical or standalone performance studies with defined acceptance criteria.
Therefore, the requested information elements (1-9) cannot be fully populated from this document. However, I can extract what is explicitly stated and explain why other information is absent.
Acceptance Criteria and Study Information (Based on Provided Text):
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by Abbreviated 510(k) and Guidance Docs) | Reported Device Performance (Implied) |
|---|---|
| Conformity with "Guidance for Industry and FDA Staff: Dental Cements - Premarket Notification (August 1998)" | The submission states "DMG-USA has provided information to demonstrate conformity with FDA's guidance document entitled Guidance for Industry and FDA Staff: Dental Cements - Premarket Notification (August 1998)." This implies that the device materials (Nanocomposite, Nanocomposite Flowable, MDP One Bottle Bond) meet the safety and performance requirements outlined in this guidance for dental cements aspects. |
| Conformity with "Guidance for Industry and FDA Staff: Dental Composite Resin Devices - Premarket Notification [510(k)] Submissions (October 2005)" | The submission states "...and Guidance for Industry and FDA Staff: Dental Composite Resin Devices -Premarket Notification [510(k)] Submissions (October 2005)." This implies that the composite materials (Nanocomposite, Nanocomposite Flowable) meet the safety and performance requirements outlined in this guidance for dental composite resin devices. |
| Substantial Equivalence to Predicate Devices (Implied) | The conclusion states: "Based on the indications for use, technological characteristics, and comparison to the predicate devices, the Nanocomposite Restorative Kit has been shown to be safe and effective for its intended use." This indicates that the device performs similarly in terms of safety and effectiveness to the identified predicate devices: |
- Nanocomposite: SternOmega Composite LC (K982692)
- Nanocomposite Flowable: SternOmega Composite LC (K982692)
- MDP One Bottle Bond: Clearfil tri-S bond (K042913) |
2. Sample size used for the test set and the data provenance:
- Not explicitly stated. For an Abbreviated 510(k) relying on guidance compliance and substantial equivalence, specific "test sets" with sample sizes like those for a novel clinical trial are typically not provided in the summary. Performance data often comes from bench tests and literature review, not new patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not stated. Ground truth establishment by experts in the context of clinical study data is not described here. This submission relies on technical characteristics and conformity to existing standards and predicate devices.
4. Adjudication method for the test set:
- Not applicable/Not stated. Adjudication methods are relevant for studies involving human interpretation or clinical data, which are not detailed in this summary.
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:
- No MRMC study was done. This device is a dental restorative material, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study and AI-related effect sizes are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical restorative material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not explicitly stated in this summary for new data. For an Abbreviated 510(k) of a material, "ground truth" often refers to well-established material properties (e.g., bond strength, flexural strength, wear resistance, color stability) measured through standard laboratory tests, or the known performance and safety profiles of the predicate devices. The conformity to guidance documents implies that accepted methodologies for evaluating dental materials were followed.
8. The sample size for the training set:
- Not applicable/Not stated. This is not an AI/machine learning device that would require a training set.
9. How the ground truth for the training set was established:
- Not applicable/Not stated. As above, no training set for an algorithm is involved.
Summary of the Study (Implied by Abbreviated 510(k)):
The "study" refers to the documentation and data presented to FDA to demonstrate conformity to recognized guidance documents and substantial equivalence to legally marketed predicate devices.
- Purpose: To demonstrate that the Nanocomposite Restorative Kit (Nanocomposite, Nanocomposite Flowable, and MDP One Bottle Bond) is safe and effective for its intended uses and is substantially equivalent to existing predicate devices.
- Methodology: The submission is an Abbreviated 510(k). This approach involves:
- Providing information to demonstrate conformity with specific FDA guidance documents for dental cements and composite resin devices. These guidances typically outline the types of bench tests and characterization data expected for these materials (e.g., physical, mechanical, chemical properties, biocompatibility).
- Comparing the new device's technological characteristics and intended uses to those of predicate devices already on the market.
- Data Provenance: The data primarily comes from bench testing done by the manufacturer or third-party labs to demonstrate conformity to standards and guidances. It also relies on the established safety and effectiveness profiles of the predicate devices. No clinical trial data or patient data source (e.g., country of origin, retrospective/prospective) is explicitly mentioned for new studies.
- Results (Conclusion): "Based on the indications for use, technological characteristics, and comparison to the predicate devices, the Nanocomposite Restorative Kit has been shown to be safe and effective for its intended use." This means the manufacturer successfully demonstrated that their new material performs comparably to the predicate devices and meets the requirements of the relevant FDA guidance documents.
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.