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510(k) Data Aggregation
K Number
K051008Device Name
SET
Manufacturer
Date Cleared
2005-06-15
(56 days)
Product Code
Regulation Number
872.3275Why did this record match?
Applicant Name (Manufacturer) :
SOUTHERN DENTAL INDUSTRIES, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Indirect cementation of ceramic, composite and metal inlays, onlays, crowns, bridges, posts, screws and veneers.
Device Description
Not Found
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K Number
K012528Device Name
ICE
Manufacturer
Date Cleared
2001-10-22
(77 days)
Product Code
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
SOUTHERN DENTAL INDUSTRIES, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Microfil hybrid restorative for all cavity classes, veneers and diastema closures.
Device Description
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K Number
K012529Device Name
ROK
Manufacturer
Date Cleared
2001-10-22
(77 days)
Product Code
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
SOUTHERN DENTAL INDUSTRIES, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
High density restorative for cavity preparation in posterior teeth. May be used as an indirect restorative for inlays and onlays.
Device Description
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