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510(k) Data Aggregation
K Number
K193357Device Name
V-Mix
Manufacturer
Inter-Med/ Vista Dental Products
Date Cleared
2020-10-23
(324 days)
Product Code
KJJ
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Inter-Med/ Vista Dental Products
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
V-Mix is used for debridement, removing the smear layer, and cleansing the root canal system.
Device Description
V-Mix is a two-part, dual-action root canal cleanser. V-Mix A is an aqueous solution that contains carboxylic acid chelating agents and surfactants. V-Mix B is an aqueous solution that contains sodium hypochlorite. Once the two solutions are mixed, the mixed solution cleanses and debrides the root canal system by removing the organic and inorganic debris during and after endodontic instrumentation.
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