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510(k) Data Aggregation
K Number
K011659Device Name
GPW-SF
Manufacturer
Date Cleared
2001-08-27
(90 days)
Product Code
Regulation Number
872.3060Why did this record match?
Applicant Name (Manufacturer) :
GATEWAY ALLOYS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
GPW-SF is a high fusing white colored gold based solder for brazing porcelain-fused-to-metal alloys prior to the application and firing of the porcelain enamel. It is intended for use in the manufacture of single units, short-span and long-span bridges.
Device Description
GPW-SF Solder
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K Number
K011661Device Name
CONCORD 88
Manufacturer
Date Cleared
2001-08-27
(90 days)
Product Code
Regulation Number
872.3060Why did this record match?
Applicant Name (Manufacturer) :
GATEWAY ALLOYS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
CONCORD 88 (PM-43) is a yellow colored gold/platinum dental casting alloy for restorations subject to high stress and that require porcelain enamels be fused to some of the surfaces. It may also be used as a Type III (hard) crown and bridge alloy. It is intended for use in the manufacture of single units, ¾ crowns, and short-span bridgework.
Device Description
CONCORD 88 (PM-43) is a yellow colored gold/platinum dental casting alloy.
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K Number
K011626Device Name
CONCORD 72
Manufacturer
Date Cleared
2001-07-16
(48 days)
Regulation Number
872.3060Why did this record match?
Applicant Name (Manufacturer) :
GATEWAY ALLOYS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
CONCORD 72 (PM-41) is a yellow colored gold/platinum dental casting alloy for restorations subject to high stress and that require low fusing porcelain enamels be fused to some of the surfaces. It may also be used as a Type IV (Extra Hard) crown and bridge alloy. It is intended for use in the manufacture of single units, % crowns, and short-span and long-span bridgework.
Device Description
CONCORD 72 (PM-41) is a yellow colored gold/platinum dental casting alloy.
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K Number
K011628Device Name
CONCORD 82
Manufacturer
Date Cleared
2001-07-16
(48 days)
Product Code
Regulation Number
872.3060Why did this record match?
Applicant Name (Manufacturer) :
GATEWAY ALLOYS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
CONCORD 82 (PM-41) is a yellow colored gold/platinum dental casting alloy for restorations subject to high stress and that require porcelain enamels be fused to some of the surfaces. It may also be used as a Type IV (Extra Hard) crown and bridge alloy. It is intended for use in the manufacture of single units, % crowns, and short-span and long-span bridgework.
Device Description
Not Found
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K Number
K964940Device Name
TAOS 28
Manufacturer
Date Cleared
1997-01-13
(34 days)
Product Code
Regulation Number
872.3060Why did this record match?
Applicant Name (Manufacturer) :
GATEWAY ALLOYS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K964941Device Name
EL DORADO 40
Manufacturer
Date Cleared
1997-01-13
(34 days)
Product Code
Regulation Number
872.3060Why did this record match?
Applicant Name (Manufacturer) :
GATEWAY ALLOYS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K964948Device Name
AURORA 52 (PM-01)
Manufacturer
Date Cleared
1997-01-13
(34 days)
Product Code
Regulation Number
872.3060Why did this record match?
Applicant Name (Manufacturer) :
GATEWAY ALLOYS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K964949Device Name
AURORA 53
Manufacturer
Date Cleared
1997-01-13
(34 days)
Product Code
Regulation Number
872.3060Why did this record match?
Applicant Name (Manufacturer) :
GATEWAY ALLOYS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K964950Device Name
LA PLATA 28 (PM-28)
Manufacturer
Date Cleared
1997-01-13
(34 days)
Product Code
Regulation Number
872.3060Why did this record match?
Applicant Name (Manufacturer) :
GATEWAY ALLOYS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K964788Device Name
EL DORADO 55
Manufacturer
Date Cleared
1996-12-20
(21 days)
Product Code
Regulation Number
872.3060Why did this record match?
Applicant Name (Manufacturer) :
GATEWAY ALLOYS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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