Search Results

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.

Ask a specific question about this device