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510(k) Data Aggregation
K Number
K241568Device Name
CrystLCare PRO Biorestorative, Fluoride-Plus
Manufacturer
GreenMark Biomedical Inc.
Date Cleared
2025-01-02
(216 days)
Product Code
LBH
Regulation Number
872.3260Why did this record match?
Applicant Name (Manufacturer) :
GreenMark Biomedical Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Indicated for relief of discomfort from dentin sensitivity.
Device Description
CrystLCare™ PRO Biorestorative, Fluoride-Plus is a flavored dental strip which contains calcium, phosphate, and fluoride which are stabilized with a modified starch. The single-use strip is topically applied to the outer surface of a tooth or teeth that are experiencing dental sensitivity. The strip dissolves in salivator elease these minerals which then will precipitate crystals that form a layer over the tooth surfaces. This physically occludes exposed dentinal tubules and enamel porosities to relieve discomfort. The modified starch helps to stabilize the calcium, phosphate, and fluoride mineral components so that they can persity into the dentinal tubules.
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K Number
K200601Device Name
LumiCare Caries Diagnostic Rinse
Manufacturer
GreenMark Biomedical Inc.
Date Cleared
2021-03-29
(385 days)
Product Code
LFC, EAQ
Regulation Number
872.1740Why did this record match?
Applicant Name (Manufacturer) :
GreenMark Biomedical Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To aid the dental professional in visualization of carious lesions
Device Description
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.
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