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Found 12 results
510(k) Data Aggregation
K Number
K003387Device Name
AUROFILM NP
Manufacturer
Date Cleared
2001-01-09
(70 days)
Product Code
Regulation Number
872.3710Why did this record match?
Applicant Name (Manufacturer) :
METALOR DENTAL USA CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K993475Device Name
AUROFLUID M, ALLOY NO. 5315
Manufacturer
Date Cleared
1999-12-09
(56 days)
Product Code
Regulation Number
872.3060Why did this record match?
Applicant Name (Manufacturer) :
METALOR DENTAL USA CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Fabrication of Dental Crowns, Bridges, Inlays and Cast Partial-denture Frames.
Device Description
Not Found
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K Number
K993505Device Name
V-DELTA SPECIAL, ALLOY NO. 5154
Manufacturer
Date Cleared
1999-12-08
(54 days)
Regulation Number
872.3060Why did this record match?
Applicant Name (Manufacturer) :
METALOR DENTAL USA CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Fabrication of Porcelain-Fused-to-Metal Dental Crowns, Bridges, and Implant-supported Prosthesis Substructures.
Device Description
Not Found
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K Number
K993506Device Name
PAGALINOR 4 , ALLOY NO. 5440
Manufacturer
Date Cleared
1999-12-08
(54 days)
Product Code
Regulation Number
872.3060Why did this record match?
Applicant Name (Manufacturer) :
METALOR DENTAL USA CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Fabrication of Dental Crowns, Bridges, Inlays and Low-fusing Porcelain-fused-to-metal Applications.
Device Description
Not Found
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K Number
K993507Device Name
V-SUPRAGOLD, ALLOY NO. 5024
Manufacturer
Date Cleared
1999-12-06
(52 days)
Product Code
Regulation Number
872.3060Why did this record match?
Applicant Name (Manufacturer) :
METALOR DENTAL USA CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Fabrication of Porcelain-Fused-to-Metal Dental Crowns and Bridges.
Device Description
Not Found
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K Number
K993508Device Name
V-SUPRA PLUS, ALLOY NO. 5025
Manufacturer
Date Cleared
1999-12-06
(52 days)
Product Code
Regulation Number
872.3060Why did this record match?
Applicant Name (Manufacturer) :
METALOR DENTAL USA CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Fabrication of Porcelain-Fused-to-Metal Dental Crowns, Bridges, and Implant-supported Prosthesis Substructures.
Device Description
Not Found
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K Number
K993474Device Name
DELTAPAL, ALLOY NO. 5161
Manufacturer
Date Cleared
1999-12-02
(49 days)
Product Code
Regulation Number
872.3060Why did this record match?
Applicant Name (Manufacturer) :
METALOR DENTAL USA CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
For use in the Fabrication of Porcelain-Fused-to-Metal Dental Crowns, Bridges and Implant-supported Prosthesis Substructures.
Device Description
Not Found
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K Number
K982606Device Name
AUROFLUID CPF
Manufacturer
Date Cleared
1998-10-15
(80 days)
Product Code
Regulation Number
872.3060Why did this record match?
Applicant Name (Manufacturer) :
METALOR DENTAL USA CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
For Use in the Fabrication of Dental Crowns, Bridges, Inlays and Onlays.
Device Description
Not Found
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K Number
K973372Device Name
AUROFILM 2000
Manufacturer
Date Cleared
1997-11-26
(79 days)
Product Code
Regulation Number
872.3060Why did this record match?
Applicant Name (Manufacturer) :
METALOR DENTAL USA CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
For Enhancement of Porcelain Bond and Color in Porcelain Fused-to-Metal Dental Crowns and Bridges.
Device Description
Not Found
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K Number
K972683Device Name
V-DELTA 450
Manufacturer
Date Cleared
1997-08-18
(32 days)
Product Code
Regulation Number
872.3060Why did this record match?
Applicant Name (Manufacturer) :
METALOR DENTAL USA CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
For use in the Fabrication of Porcelain-Fused-to-Metal Dental Crowns and Bridges.
Device Description
Not Found
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