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Cleanse. Freshen. Go. Aligner Cleansing Towelette is indicated for OTC use to remove oral debris and kill odor causing bacteria associated with removable dental appliances.
Cleanse.Freshen.Go. Dental Appliance Cleanser is indicated for OTC use to remove oral debris and kill odor causing bacteria associated with removable dental appliances.

Cleanse.Freshen.Go. Aligner Cleansing Towelette is a cleansing solution impregnated onto a towelette for cleaning oral debris from removable dental appliances. It does not require dilution or activation and the pre-moistened towelette is supplied in compact and portable foil laminated hermetically sealed packages. The ready-to-use product form enables faster and more frequent cleansing of removable dental appliances in locations otherwise found to be impractical with many denture cleanser alternatives.
Cleanse.Freshen. Go. Dental Appliance Cleanser is a spray liquid cleansing solution for cleaning oral debris from removable dental appliances. It does not require dilution or activation and is supplied in a 2 oz. plastic pump spray bottle that is compact and portable. The ready-to-use product form enables faster and more frequent cleansing of removable dental appliances in locations otherwise found to be impractical with many denture cleanser alternatives.

Here's the analysis of the provided text regarding acceptance criteria and study information:

This document does not contain information about acceptance criteria or a study that proves a device meets such criteria.

The provided text is a 510(k) summary for two denture cleanser products: "Cleanse.Freshen.Go. Aligner Cleansing Towelette" and "Cleanse.Freshen.Go. Dental Appliance Cleanser."

It primarily focuses on:

• Device Identification: Trade names, common names, classification, and predicate devices.
• Intended Use: Cleaning oral debris and killing odor-causing bacteria on removable dental appliances.
• Device Description: Physical characteristics (towelette vs. spray, packaging, ready-to-use nature).
• FDA Communication: A letter from the FDA to the applicant (Oral Health Technologies, LLC) stating that the devices are substantially equivalent to legally marketed predicate devices and can be marketed. This letter also outlines regulatory responsibilities.
• Indications for Use: Formal statements for both devices, reiterating their purpose.

Therefore, I cannot populate the table or answer the specific questions you've asked because the information is not present in the provided text.

The 510(k) process for this type of device (OTC Denture Cleanser, Class I) typically relies on demonstrating substantial equivalence to a predicate device, rather than requiring extensive clinical trials with pre-defined acceptance criteria and detailed performance studies like those seen for higher-risk medical devices or AI algorithms. The "study" mentioned here is implicitly the comparison to the predicate device, which the FDA has deemed sufficient for market clearance based on the information provided by the manufacturer.

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

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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.

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Ask a specific question about this device