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510(k) Data Aggregation
K Number
K012877Device Name
HIGH GOLD PALLADIUM FREE CERAMIC SOLDER
Manufacturer
IVOCLAR USA, INC.
Date Cleared
2001-11-21
(86 days)
Product Code
EJT
Regulation Number
872.3060Why did this record match?
Applicant Name (Manufacturer) :
IVOCLAR USA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Used for brazing dental alloys prior to porcelain application.
Device Description
High Gold Palladium Free Ceramic Solder
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K Number
K981264Device Name
ARISTON PHC
Manufacturer
IVOCLAR USA, INC.
Date Cleared
1998-07-02
(86 days)
Product Code
EBF
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
IVOCLAR USA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intended Use: Ariston pHc filling material is intended to be used for Intended USE. Allscon pho firming indeciduous and permanent teeth with Crass I and if reparations and for an amalgam substitute.
Device Description
Not Found
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K Number
K980986Device Name
PROCAD
Manufacturer
IVOCLAR USA, INC.
Date Cleared
1998-05-11
(55 days)
Product Code
EIH
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
IVOCLAR USA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intended Use: ProCad is intended to be used for inlays, onlays, veneers, and anterior/posterior crowns.
Device Description
Not Found
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