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Bonding between dentin/enamel and silorane based composite filling materials

Bonding between dentin/enamel and methacrylate based composite filling materials

Bonding mediator for fissure sealing

Hermes Bond 2 is classified as Resin Tooth Bonding Agent (21 C.F.R. § 872.320(1) because it is a device intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restorative material.

Like Adper Prompt L-Pop, 3M ESPE's well-known and well-established resin bonding agent, Hermes Bond 2 offers the advantages of a simplified bonding procedure, eliminating the need for a separate etching step. Thus it reduces both possible errors during application and post-operative sensitivity. Additionally, it saves the dentist valuable chair time. Being based on methacrylate chemistry itself, Hermes Bond 2 is well suited for bonding methacrylate composites. The compatibility to silorane based composites is ensured by the formulation of Hermes Bond 2 which has especially becu optimized for this purpose. In fact, the bond strength obtained for Hermes/Hermes Bond 2 is comparable to that of Adper Prompt L-Pop with conventional methacrylate composites.

Hermes Bond 2 is also intended to be used as a bonding mediator for fissure sealing as is Adper Prompt L-Pop.

Like Adper Prompt L-Pop, Hermes Bond 2 will be available in single dose applicators and in a two-vial version.

The provided text is a 510(k) summary for a dental adhesive called Hermes Bond 2. It details the device's classification, comparison to predicate devices, and a statement on safety and effectiveness. However, it does not contain the specific information required to answer your request about acceptance criteria and the study proving the device meets those criteria.

The 510(k) summary makes a general statement that "The comparison for chemistry, performance data and indications for use shows that Hermes Bond 2 is substantially equivalent to the predicate devices" and "In summary, it can be concluded that safety and effectiveness requirements for Hermes Bond 2 are completely met." It also mentions that "biocompatibility testing was carried out. The results show that Hermes Bond 2 is a safe device."

However, it does not include:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for the test set or data provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method.
• Information on a Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
• Information on a standalone (algorithm only) performance study.
• The type of ground truth used (e.g., pathology, outcomes data).
• Sample size for the training set.
• How ground truth for the training set was established.

The document focuses on demonstrating substantial equivalence to predicate devices (Adper Prompt L-Pop, RelyX Unicem, Protemp 3 Garant) based on chemistry, performance data (implied to be comparable bond strength), and indications for use, rather than presenting a detailed study with specific acceptance criteria and results. The "performance data" mentioned is likely referring to bond strength, with the statement that "the bond strength obtained for Hermes/Hermes Bond 2 is comparable to that of Adper Prompt L-Pop with conventional methacrylate composites," but no specific metrics or acceptance criteria are given.

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