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510(k) Data Aggregation
K Number
K983374Device Name
AGATHA-A-H2010
Manufacturer
MIDIAN INTL.
Date Cleared
1998-12-23
(89 days)
Product Code
EFS
Regulation Number
872.6510Why did this record match?
Applicant Name (Manufacturer) :
MIDIAN INTL.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To Remove adherent plaque and debris from the teeth and oral mucosa, to Reduce tooth decay in patients who are Physically unable to perform brushing. To Prevent Aspiration, which may be associated with mechanical brushing only in these patients.
Device Description
Not Found
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