(193 days)
Signum metal bond:
- Bonding agent between framework surfaces made of metal alloys (precious metal, non-precious metal or titanium) and (meth-) acrylate-based veneering materials in conjunction with micromechanical retention.
- Bonding agent between partial framework surfaces made of metal alloys (precious metal, nonprecious metal or titanium) and (meth-) acrylate-based veneering materials or denture base materials (hot or auto-polymerizates).
- Bonding agent for extraoral repair of metal supported composite veneers.
Signum universal bond:
Metal
- Bonding agent between framework surfaces made of metal alloys (precious metal, non-precious metal or titanium) and (meth-) acrylate-based veneering materials in conjunction with macromechanical retentions.
- Bonding agent between partial framework surfaces made of metal alloys (precious metal, nonprecious metal or titanium) and (meth-) acrylate-based veneering materials or denture base materials (hot or auto-polymerizates).
- Bonding agent for the extraoral repair of metal-supported composite veneers.
Zirconium dioxide - Bonding agent between frameworks, implant abutments and single crowns made of ZrO3 and lightcuring veneering materials.
- Bonding agent for the extraoral repair of composite veneers on ZrO2 frameworks.
High performance polymers (PEEK) - Bonding agent between frameworks, implant abutments and individual crowns made of high performance polymers and light-curing veneering materials.
- Bonding agent between partial framework surfaces made of high-performance polymers and lightcuring veneering materials or denture base materials (hot or auto-polymerizate).
- Bonding agent for the extraoral repair of composite veneers on PEEK frameworks.
Signum liquid:
For light-curing veneering materials from Kulzer:
- Restoring the dispersion layer of light curing veneering materials.
Signum composite / Signum composite flow / Signum matrix:
Suitable for veneering the following dental framework materials: Metal alloys (precious metal, non-precious or titanium), zirconia, high-performance polymers (PEEK)
Suitable for partial alteration of the colour and shape of the following dental materials:
• PMMA
• Photopolymers
Suitable for the following prosthetic restorations:
• full and partial veneers for permanent framework-supported crowns and bridges
• veneering removable combination prosthetics (telescopic and tapered crowns and at-tachment prosthetics)
• veneering of superstructures/tertiary structures on implants
• metal-free front tooth and posterior tooth temporary restorations
• alteration of the colour and shape of Kulzer acrylic denture teeth
• alteration of the colour and shape of acrylic-based frameworks (PMMA).
• alteration of the colour and shape of Kulzer photopolymers that are approved for char-acterisation with Signum components (according to the photopolymer instructions for use)
Signum cre-active:
Individual characterization (e.g., of enamel cracks, white spots, imitation fillings, enamel wedges, intermediate colour layers, abrasion surfaces, fissures) of
• light-curing Kulzer veneering materials,
• Kulzer denture acrylic teeth and PMMA,
• (meth-)acrylate-based 3D printing photopolymers in accordance with the photopolymer instructions for use
Signum Bondings (Signum metal bond) are intended for dental works in the laboratory as an adhesion promoter between a given framework made of zirconium dioxide, dental alloys, high performance composites, PMMA, and a second material (e.g. composites or acrylics). These primers are only applied in the laboratory. After restorative work, Signum bondings are encapsulated between framework and the restoration/veneering material and a direct contact to the patient is very unlikely. Signum metal bond is a liquid stored in a 5 mL bottle with dropper and red cap.
Signum universal bond is a liquid stored in a 5 mL bottle with dropper and blue cap.
Signum liquid is indicated for light-curing materials from Kulzer to simplify modeling procedures and restore the dispersion layer of light-curing veneering materials.
Signum liquid is foreseen for dental works in the laboratory, where an adhesion promoter between a given composite layer and a second acrylate based material, including procedures is necessary. After completion of the restorative work, Signum liquid is encapsulated between both layers and a direct contact to the patient is very unlikely. Signum liquid is a liquid stored a 5 mL bottle with a spout and red cap.
Signum composite, Signum composite flow, and Signum matrix are veneering composites for crowns and bridges. The veneering composites are processed by dental technicians for dental restoration by veneering framework supported restorations (for example metal or zirconia frameworks).
After light activated polymerization is inserted into the oral cavity of a specific patient as a custom made device, adapted and connected to the remaining residual teeth or functionally adapted.
The veneering composites are pastes stored in a syringe featuring a plunger and a closing cap.
Signum cre-active are a light-curing color fluids for crown and bridge techniques and prosthetics.
Signum cre-active is used in the dental laboratory to create customized characterizations of dental prosthetic works, that are then inserted into the oral cavity of a specific patient as individualized medical devices, adapted, and connected to the remaining residual teeth or functionally adapted to the edentulous alved Signum cre-activelayers must be covered with veneering material, there is no direct patient contact.
Signum cre-active are liquids stored in a syringe featuring a plunger and a closing cap.
This is a 510(k) summary for a dental device, not a diagnostic AI/ML device. Therefore, the common acceptance criteria and study attributes for AI/ML devices, such as sensitivity, specificity, MRMC studies, ground truth establishment, expert qualifications, and training/test set sizes, are not applicable here.
This document describes the equivalence of several dental materials (Signum composite flow, Signum universal bond, Signum metal bond, Signum composite, Signum matrix, Signum liquid, Signum cre-active) to previously cleared predicate devices based on their intended use, technological characteristics, and performance data from non-clinical testing and literature review.
However, I can extract information related to performance testing that was done and the "acceptance criteria" through a generalized understanding.
Performance Criteria and Device Performance (Generalized to Non-AI/ML Devices)
| Acceptance Criteria (Performance Metric) | Reported Device Performance |
|---|---|
| Mechanical Testing: | |
| Depth of Cure (for composites) | Performed |
| Flexural Strength (for composites) | Performed |
| Bond Strength (for composites) | Performed |
| Shear Bond Strength (for bondings with various materials like precious metal, non-precious metal, zirconium, PEEK) | Performed |
| Viscosity (for cre-active) | Performed |
| Curing Depth (for cre-active) | Performed |
| Thermal Testing: | |
| Shelf-life stability at differing temperatures | Performed |
| Overall Safety and Performance | Proven through non-clinical testing and scientific literature review |
| Clinical Equivalence | Demonstrated through comparison to predicate devices and literature review |
| Benefit-Risk Ratio | Positive for all components |
Study Details (as inferable for non-AI/ML medical devices):
-
Sample Size used for the test set and the data provenance: Not explicitly stated as "sample size for test set" in the context of an AI/ML device. For mechanical and thermal testing, the sample size would refer to the number of material specimens tested, but this is not disclosed. The data provenance includes "internal data and scientific literature."
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as this is not an AI/ML diagnostic device requiring expert-established ground truth. The "ground truth" here is the performance of the material against established standards for dental materials.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as this is not an AI/ML diagnostic device with expert adjudication.
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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 not an AI/ML diagnostic device.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI/ML device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): For this type of device, the "ground truth" or reference standard for performance is established through internationally recognized standards for dental materials (e.g., ISO standards) that dictate acceptable ranges for mechanical, physical, and chemical properties. The submission refers to "internal data" and "scientific literature" to support the safety and performance, implying adherence to these established benchmarks.
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The sample size for the training set: Not applicable. This is not an AI/ML device.
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How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.
Additional Information from the Document:
- Study Type: The submission relies on non-clinical in vitro testing (for mechanical and thermal properties) and a literature-based clinical evaluation for all components.
- "Clinical evaluation is based on internal data and scientific literature currently available." This indicates that no new prospective clinical trials were conducted for this 510(k) submission. Instead, the safety and effectiveness are supported by existing knowledge and data.
- Predicate Device Comparison: The "acceptance criteria" for demonstrating substantial equivalence are primarily met by showing that the new devices have similar intended uses, technological characteristics, and performance to legally marketed predicate devices, which have already demonstrated safety and effectiveness.
- Long-standing Market Presence: Many components ("Signum composite is marketed since 1999, Signum composite flow since 2011 and Signum matrix since 1999," "Signum metal bond is marketed since 2007, Signum universal bond since 2022 and Signum liquid since 1983," "Signum cre-active is marketed since 1991") have a long history of safe use, further supporting their equivalence.
§ 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.