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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 Desensitization of hypersensitive areas of teeth Bonding between RelyX™ Fiber Post root posts and light-curing composite core build-up materials

Adper Prompt/Adper Prompt L-Pop is classified as 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). Additionally, Adper Prompt/Adper Prompt L-Pop can be used to scal dentinal tubules of exposed root surfaces to prevent from dentinal hypersensitivity. Furthermore, as recent results show, Adper Prompt L-Pop is suited to bond RelyX™ Fiber Post, glassfiber-reinforced root canal posts by 3M ESPE, to light-curing composite core build-up materials.

The provided text does not contain specific acceptance criteria or a study design to prove that the device meets those acceptance criteria in the format requested. The document is a 510(k) summary for a dental adhesive (Adper Promote/Adper Prompt L-Pop) seeking clearance for a new indication: bonding between RelyX™ Fiber Post root posts and light-curing composite core build-up materials.

Instead of presenting quantitative acceptance criteria and a detailed study report, the document states:

• "Performance and comparative testing of Adper Prompt/Adper Prompt L-Pop has been carried out."
• "The results suggest that Adper Prompt/Adper Prompt L-Pop is a suitable agent for bonding between RelyX Fiber Post root posts, by 3M ESPE, and light-curing composite core build-up materials."
• "The data provided in this 510(k) submission shows that Adper Prompt/Adper Prompt L-Pop is substantially equivalent to the predicate devices."

The document focuses on substantiating substantial equivalence to a predicate device rather than providing a detailed performance study against predefined acceptance criteria for the new indication. Therefore, I cannot extract the information required for the table and bullet points as it is not present in the provided text.

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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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Bonding of Enamel/Dentin and Compomer Restorative Materials

РкомРт® L-Pop® is classified as a 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 restorative material). PROMP® L-POP® is similar and substantially equivalent in intended use, composition, and function to ESPE'S compomer bonding material HYTAC® OSB. The filler of PROMPT® L-POP® is contained in Zhermack's alginate based impression material HYDROGUM®. ESPE's composite luting cement COMPOLUTE® contains the same photo initiator.

The provided text is a 510(k) summary for a dental device, PROMPT® L-POP®. It outlines the device description, classification, and substantial equivalence to predicate devices. However, it does not include any information about acceptance criteria, analytical or clinical studies, performance data, or ground truth establishment.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is absent from the provided text.

Specifically, the following information cannot be extracted:

1. A table of acceptance criteria and the reported device performance: Not present. The document only mentions predicate devices are "well established and determined to be safe and effective," but provides no specific criteria or performance data for PROMPT® L-POP®.
2. Sample sizes used for the test set and the data provenance: Not present. No study details are provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present. No study details are provided.
4. Adjudication method for the test set: Not present. No study details are provided.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not present. No study details are provided.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not present. This device is a component (bonding agent), not an algorithm.
7. The type of ground truth used: Not present. No study details are provided.
8. The sample size for the training set: Not present. No study details are provided.
9. How the ground truth for the training set was established: Not present. No study details are provided.

The document is a regulatory submission focusing on the device's substantial equivalence to previously approved devices based on its intended use, composition, and function, rather than presenting a detailed performance study with acceptance criteria.

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