(164 days)
DiscovRED™ is indicated for use to detect carious dentine.
The product, DiscovRED™, is classified into the Caries Detection Device category of CFR 21, Section 872.1740.
DiscovRED™, as well as the Predicate Device, Caries Detector, is a red dye agent that when applied to the suspected carious areas of the tooth stains the carious dentine.
DiscovRED™ is a caries detector. Both devices have a two year shelf-life.
DiscovRED™ is for Prescription Use only and not over-the-counter use.
The method of operation and placement of DiscovRED™ is similar to that of the Predicate Device, Caries Detector. A drop of the detector is applied to the carious dentine, rinsed with water and air dispersed. The stained carious tissue is then removed with a low speed rotary bur. The process may be repeated until there are no more stainable tissues in the cavity.
DiscovRED™ and the Predicate Device do not involve chemical reactions.
DiscovRED™ and the Predicate Device do not use any power-assisted devices such as optical light emitting or electrical energy forms.
This document describes a medical device, DiscovRED™, and its substantial equivalence to a predicate device, Caries Detector. However, it does not contain information about specific acceptance criteria, a study demonstrating the device meets those criteria, or details regarding sample sizes, ground truth establishment, or expert involvement for such a study.
The provided text is a 510(k) summary and FDA clearance letter, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed performance study results against predefined acceptance criteria. Instead, it highlights similar technological characteristics, intended use, and safety profiles to the predicate.
Therefore, the requested details for the table and subsequent points cannot be extracted from the given information. The document serves as a regulatory filing for market clearance based on equivalence, not a performance study report.
§ 872.1740 Caries detection device.
(a)
Identification. The caries detection device is a device intended to show the existence of decay in a patient's tooth by use of electrical current.(b)
Classification. Class II.