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UltraSeal XT plus bioprotection by Nobio sealant - UltraSeal XT plus sealant for prophylactic sealing of pits and fissures and can be used where the use of a flowable composite is indicated. The bioprotection by Nobio reduces demineralization, which is part of the caries formation process.

UltraSeal XT hydro bioprotection by Nobio sealant - Use UltraSeal XT hydro sealant for prophylactic sealing of pits and fissures. The addition of the bioprotection by Nobio reduces demineralization, which is part of the caries formation process.

UltraSeal XT plus bioprotection by Nobio sealant and flowable composite – UltraSeal XT plus sealant is a 58% filled, light-cured, radiopaque, methacrylate-based, thixotropic resin sealant. It is used with PrimaDry drying and priming agent to aid in avoiding moisture contamination which can cause microleakage and poor retention. It is a Type 1 Class 2 Group 1 polymer-based dental restorative flowable resin which is suitable for occlusal surfaces. It can be used where the use of a flowable is indicated. It is compatible with adhesives and bonding agents. UltraSeal XT plus sealant has a radiopacity value of 1.44 mm of aluminum. Aluminum has a radiopacity equivalent to that of dentin. Thus, 1 mm of material (having a radiopacity equivalent to 1 mm of aluminum) has a radiopacity equivalent to that of dentin-and 2 mm of aluminum is equivalent to enamel. The addition of the bioprotection by Nobio reduces demineralization, which is part of the caries formation process.

UltraSeal XT hydro bioprotection by Nobio sealant – UltraSeal XT hydro sealant is a Class 2, 53% filled, light-cured, radiopaque, methacrylate-based, thixotropic resin sealant. It is partly hydrophobic and hydrophilic before it is cured, hydrophobic once cured, and has a selfadhesive quality. UltraSeal XT hydro sealant chemistry provides the option of a visual verification for marginal retention-with the use of a black light upon placement and at recall visits. The UV light is not included in the UltraSeal XT hydro sealant kit. The addition of the bioprotection by Nobio reduces demineralization, which is part of the caries formation process.

Some of the silica-based filler particles (max 1.2% wt/wt of the total formulation) contained in all the UltraSeal XT plus Bioprotection by Nobio and UltraSeal XT hydro Bioprotection by Nobio are decorated with quaternary ammonium functional groups that are covalently bound to the filler particles' silica core via a silane linker (herein referred to as "QASi"). Following light induced polymerization, QASi particles (produced by Nobio) remain permanently entrapped within the sealant and destroy microorganisms by contact. As the cell membrane of microorganisms is negatively charged and the QASi particles have strong positive charges, microorganisms are electrostatically attracted to the positively charged cured material's surface resulting in disruption of their cell membrane and immediate microbial lysis.

Both subject devices have a depth of cure ≥ 1.5mm, are curable at wavelengths of 385-515nm and will remain uncured after light exposure while in their primary container. UltraSeal XT plus Bioprotection by Nobio is also indicated for use as a flowable composite. It has a flexural strength of ≥ 80 MPa, Water Sortpion ≤ 40 µ g/mm3, Water Solubility ≤ 7.5 µ g/mm3, Radio-Opacity, ≥ 1mm of Al, Surface Hardness ≥ 20 HK and Ambient light sensistivity resulting in the product being physically homogeneous after 60 seconds.

The provided text focuses on the substantial equivalence determination for dental sealants and does not contain information about a medical device involving AI or machine learning. Therefore, I cannot extract acceptance criteria and study details related to AI/ML device performance from this document.

The document discusses physical and chemical properties of dental sealants and their biocompatibility, which are typically evaluated through bench testing and ISO standards, not through clinical studies with human readers or AI algorithms. As such, information regarding sample sizes for test sets, data provenance, expert adjudication, MRMC studies, standalone performance, training sets, or ground truth establishment in the context of AI/ML is absent.

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Transcend universal composite is used for direct restorations in both the anterior and posterior regions.

Transcend is a light cured, tooth shade resin composite material (Bis-GMA based) to be used for posterior and anterior tooth restorations. Transcend is radiopaque and available in a range of dentin, enamel, and body shades. It is 81% filled by weight and 58% filled by volume and has an average particle size of 0.9μm (by weight) with narrow upper limit particle distribution.

Composite Wetting Resin is a 45% filled, radiopaque light cured wetting resin. Composite Wetting Resin helps to improve the glide of the instrument during and contouring. It may be used during the placement of composite if the composite has become dry during incremental layering, or if the oxygen inhibition layer has been removed or disturbed. The wetting agent is an accessory and, if necessary, is used in conjunction with Transcend.

This is a medical device 510(k) summary for a dental restorative material, not data from a study that fits the requested format for acceptance criteria of an AI/ML device. Therefore, the requested information elements such as sample size, data provenance, number of experts, adjudication method, MRMC study, standalone performance, and ground truth establishment for training and test sets are not applicable or provided in this document content.

The provided text describes a "Transcend" tooth shade resin material and an accessory "Composite Wetting Resin." The document states that "before marketing the device, testing has been conducted to meet specified acceptance criteria." However, it does not provide specific numerical acceptance criteria or the reported device performance in a tabular format that is clearly tied to meeting those criteria, as typically seen for AI/ML device performance studies.

Instead, the document primarily focuses on demonstrating substantial equivalence to a predicate device (Amelogen Plus) and reference device (SeamFree) through comparisons of technological characteristics, intended use, composition, delivery systems, physical properties, shelf life, and adherence to relevant ISO and ADA standards.

Here's an attempt to extract relevant information, acknowledging that it doesn't align with the typical structure for AI/ML device performance:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that the device was tested against standards, and the results were within acceptable limits. It does not provide specific numerical acceptance criteria or reported values for each property.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified. Standard testing for material properties typically involves multiple samples for reproducibility, but the exact number is not detailed in this summary.
• Data Provenance: Not specified, but generally, such tests are conducted in a laboratory setting by the manufacturer or a third-party testing facility.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable/Not provided. This is not an AI/ML device requiring expert ground truth for image interpretation or diagnosis. The "ground truth" here is adherence to established material science standards.

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

• Not applicable/Not provided. The compliance is against defined material property standards, not subjective clinical assessments requiring adjudication.

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 dental material, not an AI/ML 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 dental material.

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

• The "ground truth" in this context is defined by the requirements of the standards: ISO 4049:2019 (Dentistry – Polymer-based restorative materials) and ANSI ADA 27-2016 (Polymer-based Restorative Materials) for physical properties, and ISO 10993-1:2018 for biocompatibility.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device requiring a training set.

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

• Not applicable. This is not an AI/ML device.

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