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510(k) Data Aggregation
K Number
K972234Device Name
RCT GEL ROOT CANAL THERAPY GEL
Manufacturer
Date Cleared
1997-06-30
(14 days)
Product Code
Regulation Number
872.4565Why did this record match?
Product Code :
EIC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Used in the chemical and mechanical cleansing of the root canal preparation during endodontic therapy.
Device Description
RCT GEL™ allows for cleansing action that facilitates easy removal of vital pulp tissue and necrotic pulp tissue from the root canal. It is designed to be used with endodontic irrigation with sodium hypochlorite solutions. Oxygen bubbling occurs through the release of oxygen from the carbamide peroxide. This action allows for pulp tissue, dentinal shavings and debris to float out.
The physical properties of RCT GEL™ and the predicate device are similar, i.e., pH values, viscosity, appearance, color, and odor,
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