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K Number
K021131
Device Name
CHLORAPREP
Manufacturer
CENTRIX, INC.
Date Cleared
2002-09-26

(171 days)

Product Code
LBH
Regulation Number
872.3260
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

CLEANING AND Disinfective RESTORA ીચ્ચનો work

Device Description

Not Found

AI/ML Overview

This FDA 510(k) clearance letter for the CHLORAPREP™ device, a cavity varnish (Regulation Name: Cavity Varnish, Product Code: LBH), indicates that the device has been found substantially equivalent to legally marketed predicate devices. However, this document does not contain any information regarding specific acceptance criteria, device performance metrics, or details of a study that proves the device meets such criteria.

The letter primarily focuses on the regulatory aspects of the clearance, such as:

  • Substantial Equivalence: The FDA has determined the device is substantially equivalent to predicate devices.
  • Regulatory Classification: The device is classified as Class II (Special Controls).
  • Compliance Requirements: It outlines the manufacturer's responsibilities regarding registration, listing, labeling, and good manufacturing practices.

Therefore, I cannot provide the requested information based on the provided text.

To answer your questions, I would need access to the actual 510(k) submission document or a summary thereof, which would typically include:

  1. A table of acceptance criteria and the reported device performance: This would detail the specific performance metrics (e.g., bond strength, fluoride release, antimicrobial efficacy) and the thresholds for acceptance, along with the results of tests conducted.
  2. Sample size used for the test set and the data provenance: This would specify how many samples were tested and where the data came from (e.g., in vitro lab studies, in vivo animal studies, human clinical trials, and their geographical origin and design).
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is more relevant for imaging or diagnostic devices where human interpretation is involved. For a cavity varnish, ground truth would likely be established through objective laboratory measurements or histological analysis.
  4. Adjudication method for the test set: Again, more relevant for subjective evaluations. For a material, it would be based on validated assays.
  5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: This is typically for diagnostic imaging devices, not a cavity varnish.
  6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable to this type of device.
  7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Would likely be lab measurements (e.g., chemical composition, physical properties, antimicrobial activity).
  8. The sample size for the training set: Not applicable as this is not an AI/ML device.
  9. How the ground truth for the training set was established: Not applicable.

Without the actual study report or performance data from the 510(k) submission, it's impossible to describe the acceptance criteria or the study demonstrating compliance.

§ 872.3260 Cavity varnish.

(a)
Identification. Cavity varnish is a device that consists of a compound intended to coat a prepared cavity of a tooth before insertion of restorative materials. The device is intended to prevent penetration of restorative materials, such as amalgam, into the dentinal tissue.(b)
Classification. Class II (special controls). The device, when it is an external cleaning solution, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.