(147 days)
Visalys® Core, PL-Core, PL-Core-C, PL-Core-X are dual-curing core build-up materials which are intended to be used for different types of core build-ups and luting of root posts
The Visalvs® Core / PL-Variants are all available in two delivery systems: 1:1 25ml automix catridge, 1:1 5ml double syringe. The pastes should be mixed and dispensed directly from the 5-ml-double syringe with the corresponding mixing tips (MLT Ø 3.2 mm) or using an dispensing gun DS-24 2:1/1:1 for the 25-ml-cartridge with the corresponding mixing tips (MBT Ø 4.2 mm). The Visalys® Core / PL-Core-Variants are available in four different variations: Visalys® Core, PL-Core, PL-Core-C, and PL-Core-X. The Visalys® Core / PL-Core-Variants are available in the following shades: White, Dentin, and Blue. Visalys® Core, developed by Kettenbach, is a dual-curing, fluoride-containing composite used for the fabrication of radiopaque core build-ups and core fillings. The automixing, two-component system is based on a multifunctional acryl composite. BPA or BPA precursors are not used in the manufacturing process of this device. Visalys® Core has a firm consistency with good flow behavior. It is compatible with common light and dual-curing adhesives available on the market (Active Connect Technology) and already achieves strength values as specified with self-curing. Curing can be controlled as required at any time using optional light-curing. PL-Core-C, developed by Kettenbach, is a dual-curing, fluoride-containing composite used for the fabrication of radiopaque core build-ups and core fillings. The automixing, two-component system is based on a multifunctional acryl composite. BPA or BPA precursors are not used in the manufacturing process of this device. PL-Core-C has a firm consistency with good flow behavior. It is compatible with common light and dual-curing adhesives available on the market (Active Connect Technology) and already achieves strength values as specified with self-curing. Curing can be controlled as required at any time using optional light-curing. PL-Core-X, developed by Kettenbach, is a dual-curing, fluoride-containing composite used for the fabrication of radiopaque core build-ups and core fillings. The automixing, two-component system is based on a multifunctional acryl composite. BPA or BPA precursors are not used in the manufacturing process of this device. PL-Core-X has a firm consistency with good flow behavior. It already achieves strength values as specified with self-curing, however curing can be controlled as required at any time using optional light-curing. PL-Core, developed by Kettenbach, is a dual-curing, fluoride-containing composite used for the fabrication of radiopaque core build-ups and core fillings. The automixing, twocomponent system is based on a multifunctional acryl composite. BPA or BPA precursors are not used in the manufacturing process of this device. PL-Core has a firm consistency with good flow behavior. It already achieves strength values as specified with self-curing, however curing can be controlled as required at any time using optional light-curing. Differences between the variants: 1. Visalys® Core and PL-Core C are compatible with all common light and dualcuring adhesives available on the market. 2. PL-Core and PL-Core X can be applied with bondings for which the use with dualcuring composites is recommended. 3. Radiopacity is available in 2.5mm Al (Visalys® Core and PL-Core-X) or 2.0mm Al (PL-Core-C and PL-Core).
The provided document is a 510(k) summary for the dental device Visalys® Core, PL-Core, PL-Core-C, PL-Core-X. This type of document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.
The document does not describe a clinical study in the typical sense (e.g., involving human participants, expert readers, or a specific test set with ground truth established by experts/pathology) to prove performance against acceptance criteria in the way envisioned by your request. Instead, it relies on non-clinical performance testing (bench testing) to demonstrate technical equivalence to existing predicate devices.
Therefore, many of the requested fields related to clinical study design, expert involvement, and reader performance cannot be filled from this document.
Here's the information that can be extracted, adapting to the nature of the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document defines acceptance criteria by comparing the device's technological characteristics and mechanical properties to those of predicate devices (LuxaCore Dual, MULTICORE FLOW, Rebilda DC). The "reported device performance" indicates that the new device meets these criteria by demonstrating equivalence.
| Acceptance Criteria (Demonstrate Equivalence to Predicates based on): | Reported Device Performance (Conclusion from Non-Clinical Testing) |
|---|---|
| Working time (ASTM D 4473, section 4) | Demonstrated equivalence to predicate devices |
| Cure point (ASTM D 4473, section 4) | Demonstrated equivalence to predicate devices |
| Depth of cure (ISO 4049 section 7.10) | Demonstrated equivalence to predicate devices |
| Film thickness (ISO 4049 section 7.5) | Demonstrated equivalence to predicate devices |
| Volume shrinkage (ISO 17304) | Demonstrated equivalence to predicate devices |
| Water sorption (ISO 4049 section 7.12) | Demonstrated equivalence to predicate devices |
| Solubility (ISO 4049 section 7.12) | Demonstrated equivalence to predicate devices |
| Radio-opacity (ISO 4049 section 7.14) | Demonstrated equivalence to predicate devices |
| E-Modulus (ISO 4049 section 7.11) | Demonstrated equivalence to predicate devices |
| Flexural strength (ISO 4049 section 7.11) | Demonstrated equivalence to predicate devices |
| Compressive strength (ISO 9917-1, AnnexD) | Demonstrated equivalence to predicate devices |
| Diametral tensile strength (ADA Spec. 27 section 4.3.7) | Demonstrated equivalence to predicate devices |
| Shade consistency (ANSI ADA Spec. 80) | Demonstrated equivalence to predicate devices |
| Color stability (ISO 4049 and ANSI ADA Spec. 80) | Demonstrated equivalence to predicate devices |
| Biocompatibility (ISO 10993 family, OECD 487) | Comparable to other materials on the market |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not explicitly stated for each bench test. These are material property tests typically performed on a specified number of samples (e.g., 5-10 per test for ISO standards), but the exact counts are not detailed in this summary.
- Data Provenance: The tests are "non-clinical performance testing" or "bench testing" conducted by Kettenbach GmbH & Co KG in Germany, following international (ISO) and national (ASTM, ADA) standards. This is laboratory data, not patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth for these physical and chemical property tests is established by adhering to standardized test methodologies and measurements, not by expert consensus on clinical findings.
4. Adjudication method for the test set
Not applicable. This refers to consensus building for clinical ground truth, which is not relevant for bench testing.
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 is a material science study, not an AI-based diagnostic or assistive device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a material science study, not an AI-based algorithm.
7. The type of ground truth used
For the non-clinical performance tests: The "ground truth" is the objective measurement of physical and chemical properties of the material according to established international and national standards (e.g., ISO, ASTM, ADA). For biocompatibility, established biological safety parameters are used as ground truth.
8. The sample size for the training set
Not applicable. There is no "training set" in the context of this type of material science evaluation. The evaluation involves testing the device itself against established standards and comparing its properties to predicate devices.
9. How the ground truth for the training set was established
Not applicable.
§ 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.