(79 days)
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.
§ 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.