(462 days)
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- Direct restorations using light-cured composite resin
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- Cavity sealing as a pretreatment for indirect restorations
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- Treatment of exposed root surfaces
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- Treatment of hypersensitive teeth
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- Intraoral repairs of fractured restorations
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- Post cementation and core build-ups
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- Cementation of inlays, onlays, crowns, bridges and veneers
R&D Series Nova Compo- B Plus is a Light-cure ethanol/water-based, self-etching, one-step, all in one universal adhesive. It can be used reliably in total-etch or selective-etch mode for both direct and indirect restorations. Depending on the indication, the adhesive is used as self-etching or with phosphoric acid for selective enamel etching procedures. The product is intended to be used for both direct and indirect restorations. The 4-MET RDX multi-functional carboxylate methacrylate polymer creates a 3-dimensional, high-strength bond with calcium. MDP (Methacryloyloxydecyl Dihydrogen Phosphate) monomer binds to Ca+2 ions on all surfaces of the tooth. The R&D Series Nova Compo- B Plus forms a micro-mechanical bond between the dentine channels to form the resin tags. Depending on the indication, the adhesive is used as self-etching or with phosphoric acid for selective enamel etching or total-etching procedures.
The provided text describes a 510(k) premarket notification for a dental bonding agent, R&D Series Nova Compo-B Plus. It assesses the device's substantial equivalence to predicate and reference devices based on indications for use, composition, and physical properties. However, this document does not contain information about an AI/ML-based medical device study that would involve the typical acceptance criteria and study design elements requested in the prompt (e.g., test set sample size, expert ground truth, MRMC studies, standalone performance).
The information provided is for a traditional medical device (a dental adhesive), comparing its physical properties like bond strength, appearance, and curing time to existing, legally marketed dental adhesives. It's a standard regulatory submission for a Class II medical device, focusing on bench testing and biocompatibility.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study proving an AI/ML device meets those criteria, as the provided text relates to a non-AI/ML dental bonding agent.
Specifically, the document states:
- Trade/Device Name: R&D Series Nova Compo-B Plus Bottle, R&D Series Nova Compo-B Plus Single Dose
- Regulation Name: Resin Tooth Bonding Agent
- Device Description: "R&D Series Nova Compo- B Plus is a Light-cure ethanol/water-based, self-etching, one-step, all in one universal adhesive."
This clearly indicates a chemical and physical product, not an AI/ML software device.
§ 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.