(93 days)
- All classes of fillings (according to Black) with lightcuring composite or compomer
- Cementation of indirect restorations made of composite or compomer, ceramic, and metal using RelyX™ ARC, manufactured by 3M ESPE
- Core build-ups made of light-curing composite
- Root surface desensitization
- Repair of composite or compomer fillings
- Repair of restorations veneered with composite or ceramic
- Bonding orthodontic appliances to teeth for orthodontic treatment
Uno is classified Resin Tooth Bonding Agent (21 C.F.R. § 872.3200) because it is a device intended to be painted on the interior of a prepared cavity of a tooth to improve retention of restorative materials (compomer and composite restorative material). Like Adper Prompt L-Pop, 3M ESPE's well-known and well-established resin bonding agent, Uno 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, Uno is well suited for bonding methacrylate based composites to dentin and enamel. Uno is also indicated to seal sensitive root surfaces as is Adper Prompt L-Pop. Furthermore, Uno is suited to bond orthodontic appliances to teeth for orthodontic treatment as is Prompt L-Pop. Like Adper Prompt L-Pop, Uno will be available in single dose applicators and in a vial version.
This document pertains to a 510(k) summary for a dental adhesive product called "Uno" and does not contain information about the acceptance criteria or a study proving its performance against such criteria in the context of an AI/ML device.
The provided text describes a "Resin Tooth Bonding Agent" and its substantial equivalence to predicate devices, focusing on its chemical composition, intended use (bonding restorative materials, sealing root surfaces, bonding orthodontic appliances), and biocompatibility.
Therefore, I cannot provide the requested information, such as:
- A table of acceptance criteria and reported device performance: This document is for a physical dental adhesive, not an AI/ML device.
- Sample size, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, type of ground truth, training set size, or ground truth establishment for a test set: These concepts are relevant to the evaluation of AI/ML devices, not a resin tooth bonding agent.
The document states, "To provide evidence for safety biocompatibility testing was carried out. The results show that Uno is a safe device." This is the extent of any "study" mentioned, and it only addresses biocompatibility for safety, not performance against specific clinical efficacy metrics. The primary mechanism for clearance is demonstrating "substantial equivalence" to existing, legally marketed predicate devices.
§ 872.3200 Resin tooth bonding agent.
(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.