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Bonding between dentin/enamel and composite filling materials.

Bonding between dentin/enamel and compomer filling materials.

Bonding mediator for fissure sealing

Bonding mediator for bracket attachment

РяомРт L-POP® is classified as a Resin Tooth Bonding Agent (21 С.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).

I apologize, but the provided text from the 510(k) summary for PROMPT® L-POP® (K992048) describes a dental adhesive and does not contain information about acceptance criteria for a device, a study proving it meets such criteria, or details regarding AI algorithms, ground truth establishment, or multi-reader, multi-case (MRMC) studies.

The document focuses on:

• Device identification: PROMPT® L-POP® (new formula), a resin tooth bonding agent.
• Predicate device: The old formula of PROMPT® L-POP® (K 984246).
• Reason for new 510(k): Expansion of indications for use to include bonding of composite restorative materials, in addition to compomer restorative materials.
• Safety and effectiveness claims: Stating the new formula is similar to the old, with safety evidenced by material safety data sheets and a toxicological assessment, and effectiveness by performance data.
• FDA clearance: A letter from the FDA confirming substantial equivalence to the predicate device for expanded indications.
• Indications for use: Bonding between dentin/enamel and composite/compomer filling materials, fissure sealing, and bracket attachment.

Therefore, I cannot provide the requested information about acceptance criteria, performance tables, study details, sample sizes, ground truth, expert qualifications, or MRMC studies for an AI device. The document is about a dental adhesive and its regulatory clearance.

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