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510(k) Data Aggregation
K Number
K023671Device Name
AQUEOUS ACRYLIC DISPERSION 28% W/W
Manufacturer
Date Cleared
2002-11-25
(24 days)
Product Code
Regulation Number
872.3260Why did this record match?
Applicant Name (Manufacturer) :
CHX TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Prevora Stage 2, a solution containing 28% (w/w) ammonio methacrylate copolymer Type B USP/NF with 6% (w/w) triethyl citrate USP/NF in purified water USP, is used to form a protective film or coating over a film containing chlorhexidine (i.e. Prevora Stage 1), on the teeth. The methacrylate film temporarily seals and protects the chlorhexidine film thereby ensuring the extended release of the chlorhexidine onto the teeth and into the saliva.
Prevora Stage 2 is to be applied by a licensed dental professional in a dental office, to the full dentition of the patient immediately after Prevora Stage 1 is applied and dried on these same teeth of the patient.
Device Description
Prevora Stage 2, a solution containing 28% (w/w) ammonio methacrylate copolymer Type B USP/NF with 6% (w/w) triethyl citrate USP/NF in purified water USP, is used to form a protective film or coating over a film containing chlorhexidine (i.e. Prevora Stage 1), on the teeth. The methacrylate film temporarily seals and protects the chlorhexidine film thereby ensuring the extended release of the chlorhexidine onto the teeth and into the saliva.
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