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510(k) Data Aggregation
K Number
K032175Device Name
DESENS-IONOMER
Manufacturer
Date Cleared
2003-10-09
(85 days)
Product Code
Regulation Number
872.3275Why did this record match?
Applicant Name (Manufacturer) :
MILTON HODOSH, M.D.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Used for bases, linings and to cement crowns and bridges.
It decreases post-operative sensitivity. Bonds to tooth structure.
Device Description
Glass Ionomer cement called Desens-Ionomer
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K Number
K031721Device Name
COMPOSITE RESTORATION MATERIAL
Manufacturer
Date Cleared
2003-09-11
(100 days)
Product Code
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
MILTON HODOSH, M.D.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
USED AS A Composite RESTORATIVE to REPAIR CARIOUS LESIONS MATERÍAL FOR VENEERING. AND DoTASSIum CONTA
Device Description
Not Found
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K Number
K022025Device Name
MODIFICATION TO POTASSIUM NITRATE-POLYCARBOXYLATE DENTAL CEMENT
Manufacturer
Date Cleared
2002-08-15
(56 days)
Product Code
Regulation Number
872.3250Why did this record match?
Applicant Name (Manufacturer) :
MILTON HODOSH, M.D.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
FOR LINING AND BASES UNDER AMALGAM AND/OR Composite RESTORATIONS AND FOR LUTING FULL CROWNS TO PREPARED TEETH.
Device Description
Not Found
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