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510(k) Data Aggregation
K Number
K024287Device Name
FIXOBRIDGE 3-CEMENT
Manufacturer
Date Cleared
2003-03-21
(88 days)
Product Code
Regulation Number
872.3275Why did this record match?
Applicant Name (Manufacturer) :
ADVANCED HEALTHCARE LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A temporary cement for fixing dental bridges, temporary crowns or bridges, and all metal, porcelain and acrylic crowns.
Device Description
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K Number
K023981Device Name
AHL GENERIC GLASS IONOMER LUTING CEMENT
Manufacturer
Date Cleared
2003-01-31
(60 days)
Product Code
Regulation Number
872.3275Why did this record match?
Applicant Name (Manufacturer) :
ADVANCED HEALTHCARE LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
For cementing crowns, bridges, onlays, inlays and orthodontic bands.
Device Description
AHL Generic Glass Ionomer Luting Cement
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K Number
K020376Device Name
AHL GENERIC GLASS IONOMER AESTHETIC RESTORATIVE
Manufacturer
Date Cleared
2002-04-09
(64 days)
Product Code
Regulation Number
872.3275Why did this record match?
Applicant Name (Manufacturer) :
ADVANCED HEALTHCARE LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
INDICATIONS : Class V cavities (particularly erosion lesions). Class III cavities. Posterior cavities in deciduous teeth. 'Sticky' pits and fissures. Free-hand veneering.
For use only by dental professional such as DDS or DMD. Not for use by general public or OTC. Labels will bear this caution.
Device Description
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