(166 days)
COMPOSITE 168 RESTORATIVE SYSTEM is to be used with Prime & Bond™ 2.1 Universal Light Cured Dental Adhesive System: • Indicated for cavity Classes I, II, III, IV, V, and VI in anterior and posterior teeth. •May be used as a direct restorative material ·May be used for fabrication of inlays and onlays
COMPOSITE 168 RESTORATIVE is a visible light activated, radiopaque restorative material for anterior and posterior restorations of primary and permanent teeth. It is to be used with Prime & Bond 2.1 Universal Light Cured Dental Adhesive System. This one-component. VLC composite restorative is packaged in unit dose or svringes.
Here's a breakdown of the acceptance criteria and the study information for the "COMPOSITE 168 RESTORATIVE SYSTEM" based on the provided text.
This document describes a 510(k) premarket notification for a dental restorative material, which primarily relies on demonstrating substantial equivalence to a predicate device rather than presenting novel clinical study data for new performance claims. Therefore, some of the requested information (like MRMC studies, specific sample sizes for test sets, number of experts for ground truth, etc.) is not explicitly detailed in the provided summary as it's not typically required for a substantial equivalence determination based on physical properties and known biocompatibility.
Device Name: COMPOSITE 168 RESTORATIVE SYSTEM
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Set by Standard or Predicate Equivalence) | Reported Device Performance |
|---|---|
| Physical Properties: Meets ISO Standard 4049 | Meets ISO Standard 4049 |
| Biocompatibility: Negative Ames test results for main components and prior use of components in legally marketed devices (K863092 and K941899) supporting safety and effectiveness | Ames test results were negative. Prior use of components is asserted to support biocompatibility. |
| Intended Use: Equivalent to predicate device K941899 (SDI Composites) for Class I-VI restorations in anterior and posterior teeth, direct restorative, and fabrication of inlays/onlays. | Intended use stated to be substantially equivalent to K941899. |
| Technological Characteristics: Substantially equivalent in composition to predicate device K863092 (dental composite restorative). | Stated as substantially equivalent in composition. |
2. Sample Size Used for the Test Set and Data Provenance
- The 510(k) summary does not mention a specific "test set" in the context of clinical performance evaluation with human subjects.
- The evaluation is centered on physical property testing according to ISO Standard 4049 and biocompatibility testing (Ames test). The sample sizes for these tests are not provided in the summary.
- Data Provenance: The document implies in-house or contracted laboratory testing for physical properties and biocompatibility. There is no mention of country of origin for data or whether it was retrospective or prospective in a clinical sense.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- This information is not applicable or provided in the 510(k) summary. The ground truth for physical properties is defined by adherence to the ISO Standard 4049. Biocompatibility ground truth is established by standard laboratory tests (Ames test) and prior regulatory acceptance of component materials.
4. Adjudication Method for the Test Set
- This information is not applicable or provided. The evaluation is based on objective measurements against a standard (ISO 4049) and laboratory test results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done or required for this 510(k) submission. This type of study (comparing human readers with and without AI assistance) is for diagnostics and AI-powered decision support systems, not for dental restorative materials making claims about physical properties and substantial equivalence.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- No, a standalone algorithm performance study was not done. This device is a physical dental material, not an algorithm or AI system.
7. The Type of Ground Truth Used
- For physical properties: Adherence to ISO Standard 4049 for dental resin-based filling materials.
- For biocompatibility: Results of Ames testing (negative) and historical regulatory acceptance/prior use of the constituent components.
- For intended use and technological characteristics: Substantial equivalence to predicate devices (K941899 for intended use, K863092 for composition) as determined by the FDA.
8. The Sample Size for the Training Set
- This concept of a "training set" is not applicable as the device is a physical dental material evaluated against established standards and predicate devices, not an AI/ML algorithm.
9. How the Ground Truth for the Training Set Was Established
- Not applicable for the reasons stated in point 8.
§ 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.