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510(k) Data Aggregation
K Number
K991172Device Name
IONOSIT BOND
Manufacturer
Date Cleared
1999-05-17
(40 days)
Product Code
Regulation Number
872.3275Why did this record match?
Applicant Name (Manufacturer) :
DMG CHEMISCH PHARMAZEUTISCHE FABRIK GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Ionosit Bood is indicated for use in lining and basing applications under composite, amalgam ceramic and metal restorations.
Device Description
Ionosit Bourd is a light-cure, glass ionomer liner/base material which is supplied in the form of a powder and liquid that are mixed prior to use. The liquid component contains a light sensitive polymerizable acid; the powder contains a fluoride-releasing special reactive glass.
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