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K Number
K051342
Device Name
MEDICAL INTERPOROUS
Manufacturer
BONYF AG
Date Cleared
2006-06-02

(375 days)

Product Code
EFT,NUX
Regulation Number
872.3520
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Medical Interporous is a soaking treatment for the reduction of odor causing microorganisms on dentures and orthodontic retainers.

Device Description

Not Found

AI/ML Overview

I am sorry, but based on the provided document, there is no information available regarding acceptance criteria or a study proving the device meets said criteria.

The document is a letter from the FDA to Bonyf AG concerning their 510(k) premarket notification for the "MEDICAL INTERPOROUS" device. It primarily states that the FDA has reviewed the submission and determined that the device is "substantially equivalent" to legally marketed predicate devices.

The letter explicitly mentions:

  • Trade/Device Name: MEDICAL INTERPOROUS
  • Regulation Name: OTC Denture Cleanser
  • Regulatory Class: I
  • Product Code: NUX
  • Indications for Use: "Medical Interporous is a soaking treatment for the reduction of odor causing microorganisms on dentures and orthodontic retainers."

However, it does not contain any details about:

  • Specific performance acceptance criteria (e.g., a certain percentage reduction in microorganisms).
  • Any studies conducted to demonstrate the effectiveness of the device.
  • Sample sizes for test or training sets.
  • Data provenance.
  • Expert involvement in establishing ground truth.
  • Adjudication methods.
  • MRMC studies or effect sizes.
  • Standalone algorithm performance.
  • Type of ground truth used.

This type of FDA letter for a Class I device (OTC Denture Cleanser) usually focuses on substantial equivalence to existing predicate devices, meaning the device is similar enough in intended use, technology, and safety/effectiveness to a legally marketed device that it doesn't require a Pre-Market Approval (PMA) application with extensive clinical trial data. Detailed performance studies are often not mandated to the same extent as for Class II or III devices for 510(k) clearance.

§ 872.3520 OTC denture cleanser.

(a)
Identification. An OTC denture cleanser is a device that consists of material in the form of a powder, tablet, or paste that is intended to remove debris from removable prosthetic dental appliances, such as bridges or dentures. The dental appliance is removed from the patient's mouth when the appliance is cleaned.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.