Search Results
Found 2 results
510(k) Data Aggregation
K Number
K053166Device Name
SINCLAIR ORAL RINSE
Manufacturer
Date Cleared
2006-05-17
(184 days)
Product Code
Regulation Number
872.5580Why did this record match?
Applicant Name (Manufacturer) :
SINCLAIR PHARMACEUTICALS LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
SINCLAIR ORAL RINSE helps to prevent and reduce gingivitis, when used as directed. SINCLAIR ORAL RINSE serves as an adjunct to normal mechanical oral hygiene where this has proved inadequate.
Device Description
SINCLAIR ORAL RINSE contains Delmopinol hydrochloride, an anti-plaque agent that presents a surface barrier preventing oral bacteria from adhering to and colonizing on tooth surfaces and forming dental plaque. SINCLAIR ORAL RINSE helps prevent the binding of bacteria to the tooth surfaces, thereby interfering with the primary steps of plaque formation.
Ask a Question
Ask a specific question about this device
K Number
DEN050001Device Name
DECAPINOL ORAL RINSE
Manufacturer
Date Cleared
2005-04-18
(84 days)
Product Code
Regulation Number
872.5580Why did this record match?
Applicant Name (Manufacturer) :
SINCLAIR PHARMACEUTICALS LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
Ask a Question
Ask a specific question about this device
Page 1 of 1