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Found 4 results
510(k) Data Aggregation
K Number
K973567Device Name
SOWELL COBALT-CHROME METAL ALLOY
Manufacturer
Date Cleared
1997-12-11
(83 days)
Product Code
Regulation Number
872.3710Why did this record match?
Applicant Name (Manufacturer) :
C.K. INTERNATIONAL TRADING
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
FOR PARTIALS, STAYPLATES, CLASPS AND REST ON MISSIAL OR BISTAL.
Device Description
Not Found
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K Number
K973568Device Name
SOWELL NICKEL-CHROME NON-PRECIOUS METAL ALLOY
Manufacturer
Date Cleared
1997-12-11
(83 days)
Product Code
Regulation Number
872.3710Why did this record match?
Applicant Name (Manufacturer) :
C.K. INTERNATIONAL TRADING
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
NON-PRECIOUS METAL ALLOY FOR VENEERS, CROWNS, BRIDGES, INLAYS, ONLAYS.
Device Description
Sowell Nickel-Chrome Non-Precious Metal Alloy
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K Number
K973569Device Name
SOWELL NICKEL-CHROME-MOLYBDENUM ALLOY
Manufacturer
Date Cleared
1997-12-11
(83 days)
Product Code
Regulation Number
872.3710Why did this record match?
Applicant Name (Manufacturer) :
C.K. INTERNATIONAL TRADING
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
NON-FRECIOUS METAL ALLOY, CAST CROWN, BRIDGE, INLAYS, ONLAYS AND RESTORATION.
Device Description
Not Found
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K Number
K973566Device Name
SOWELL PATENTED NON-PRECIOUS METAL ALLOY
Manufacturer
Date Cleared
1997-12-08
(80 days)
Product Code
Regulation Number
872.3710Why did this record match?
Applicant Name (Manufacturer) :
C.K. INTERNATIONAL TRADING
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
NON-PRECIOUS METAL ALLOY FOR CROWN, BRIDGE, INLAYS, ONLAY, AND RESTORATION.
Device Description
NON-PRECIOUS METAL ALLOY
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