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K Number
K984246
Device Name
PROMPT L-POP
Manufacturer
ESPE DENTAL AG
Date Cleared
1999-01-08

(42 days)

Product Code
KLE
Regulation Number
872.3200
Type
Traditional
Panel
DE
Reference & Predicate Devices
K962442,K935898,K974458
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Bonding of Enamel/Dentin and Compomer Restorative Materials

Device Description

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.

AI/ML Overview

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.

§ 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.