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To aid the dental professional in the visualization of carious lesions.

BlueCheck™ Caries Detection & Monitoring is a solution containing colored agents that, when applied to tooth surfaces following a dental prophylaxis procedure, binds to surface porosities utilizing natural hydroxyapatite-binding chemistry of the protein component of the device. This allows dental professionals to observe the visual change in tooth surface color as blue on accessible tooth surfaces. BlueCheck is intended to be used in routine dental examinations as a diagnostic tool that assists dental professionals to visualize and assess caries. BlueCheck is supplied as a liquid product in single use vials (in a pack of 10 vials).

To aid the dental professional in visualization of carious lesions

The LumiCare™ device is an oral rinse solution containing starch-based particles tagged with fluorescein. A specific volume is swished in the mouth, followed by a water rinse and air drying of teeth prior to exposure of the teeth to a blue light source with an irradiance of 450 mW/cm2 and wavelength of 450-470 nm. The clinician completes the clinical examination by observing fluorescence through light orange filter accessories, including protective eyewear, to aid the visualization of dental caries.

A visual aid for the identification of carious dentin.

Vista Dyes are colored agents that when applied to the suspected carious areas of the tooth stains the carious dentin. The method of operation and placement of Vista Dyes are similar to that of the primary predicate and reference device, Caries Finder (K955445) and Pulpdent Snoop (K964430), respectively. A drop of the dye 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 carious cavity.

DiscovRED™ is indicated for use to detect carious dentin.

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.

A visual aid for the identification of infected carious dentine.

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Caries Indicator is indicated for the following applications: Designed to be used to help identify caries in dentin.

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CARIES DETECTOR is indicated for the following applications: Detection of carious dentin

This product is classified into Caries Detection Device, CFR 21 Section 872. 1740. Two of the predicate devices listed in section 3 operate by means of applying dyes to teeth to stain areas of decay. They do not involve chemical reactions, nor use electrical current or optical instruments. The methods of operation of these devices is similar to that of plaque disclosing agents in that they stain the affected areas.

CARIES INDICATOR PLUS ( CARIES STAIN ) is indicated for detection of caries through the staining of the outer layer of carious dentin.

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Caries detection Device The Oral Potential Meter aids the dental professional in detecting potential caries. Meaurements above 10 millivolts, 1 microamp and 0.01 microwatts x seconds indicates a need for the dental professional to look at potentially carious leasions by also using other means, such as direct exploration, radiographs, etc. The OPM aids in determing potentially active caries and can not detect mineralized caries that have no potenial energy. Remineralized teeth are no longer considered carious.

The OPM is a device that measures and displays voltage and conducts through caries related to metallic restorations in the oral cavity. The dentist may be able to, on visual exam, detect caries at the margins or with x-ray under a restoration with these readings. It also provides a power measurement (energy or joules) integrated over a measured period of time and displays it. The meter has two probes that are used to make the measurements. One is a reference probe, Red, with push-button switch to turn on the meter and initiate the measurements. The other is used as the primary input, Black to the meter's electronics

For use as a color-indicator of caries demineralized dentin. The water-soluble dye differentiates between dentin infected by caries and uninfected demineralized dentin and serves as a guide for the dentist-user in conservative caries removal during restoration.

CARIES STAIN may be described as a water-soluble solution of dye in solvent that selectively stains carious, infected dentin. It differentiates between non-remineralizable and remineralizable dentin to serve as a guide for conservative caries removal while maintaining as much vital tooth structure as possible.