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510(k) Data Aggregation
K Number
K982129Device Name
ANTAGON PORCELAIN
Manufacturer
Date Cleared
1998-08-04
(48 days)
Product Code
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
EUROPEAN DENTAL IMPORTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Used by a dental lab technician, under the direction of an attending dentist, to fashion and bake porcelain veneers onto dental alloy substrates so as to create the porcelainfused-to-metal elements of a fixed or removable dental prosthesis.
Antagon Porcelain is recommended for use with any normalfusing-temperature dental ceramic alloy.
After fabrication and finishing, the completed prosthesis is approved and placed in the patient's mouth by the dentist.
Device Description
Antagon Porcelain
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K Number
K981001Device Name
ORION VESTA DENTAL ALLOY
Manufacturer
Date Cleared
1998-05-18
(61 days)
Product Code
Regulation Number
872.3060Why did this record match?
Applicant Name (Manufacturer) :
EUROPEAN DENTAL IMPORTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Used by a dental lab technician, under the direction of an attending dentist, to cast elements of fixed and removable dental prostheses:
precious metal inlays, onlays, and crowns;
precious metal bridges, bars, and attachments;
precious metal copings and bridges for porcelain-fusedto-metal restorations.
Orion Vesta is recommended for use with any normal-fusingtemperature porcelain product in porcelain-fused-to-metal restorations of from one crown up to a full-span bridge.
After fabrication and finishing the completed prosthesis is approved and placed in the patient's mouth by the dentist.
Device Description
Orion Vesta Dental Alloy
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K Number
K981002Device Name
ORION WX DENTAL ALLOY
Manufacturer
Date Cleared
1998-05-18
(61 days)
Product Code
Regulation Number
872.3060Why did this record match?
Applicant Name (Manufacturer) :
EUROPEAN DENTAL IMPORTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Used by a dental lab technician, under the direction of an attending dentist, to cast elements of fixed and removable dental prostheses:
precious metal inlays, onlays, and crowns;
precious metal bridges, bars, and attachments;
precious metal copings and bridges for porcelain-fusedto-metal restorations.
Orion WX is recommended for use with any normal-fusingtemperature porcelain product in porcelain-fused-to-metal restorations of from one crown up to a full-span bridge.
After fabrication and finishing the completed prosthesis is approved and placed in the patient's mouth by the dentist.
Device Description
Orion WX Dental Alloy
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K Number
K981000Device Name
CARRARA PORCELAIN AND CARRARA VINCENT PORCELAIN
Manufacturer
Date Cleared
1998-05-15
(58 days)
Product Code
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
EUROPEAN DENTAL IMPORTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Used by a dental lab technician, under the direction of an attending dentist, to fashion and bake porcelain veneers onto dental alloy substrates so as to create the porcelainfused-to-metal elements of a fixed or removable dental prosthesis. Carrara Porcelain and Carrara Vincent Porcelain are recommended for use only with Carrara and Cera E dental alloys. After fabrication and finishing, the completed prosthesis is approved and placed in the patient's mouth by the dentist.
Device Description
Carrara Porcelain and Carrara Vincent Porcelain
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K Number
K980661Device Name
CERA E DENTAL ALLOY
Manufacturer
Date Cleared
1998-05-01
(70 days)
Product Code
Regulation Number
872.3060Why did this record match?
Applicant Name (Manufacturer) :
EUROPEAN DENTAL IMPORTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Used by a dental lab technician, under the direction of an attending dentist, to cast elements of fixed and removable dental prostheses: precious metal inlays, onlays, and crowns; precious metal bridges, bars, and attachments; precious metal copings and bridges for porcelain-fused-to-metal restorations. When used for porcelain-fused-to-metal restorations it is intended by the manufacturer that only Carrara Porcelain products be used with the Cera E alloy. After fabrication and finishing the completed prosthesis is approved and placed in the patient's mouth by the dentist.
Device Description
Cera E Dental Alloy
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K Number
K980660Device Name
BIOGOLD PLUS DENTAL ALLOY
Manufacturer
Date Cleared
1998-04-27
(66 days)
Product Code
Regulation Number
872.3060Why did this record match?
Applicant Name (Manufacturer) :
EUROPEAN DENTAL IMPORTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Used by a dental lab technician, under the direction of an attending dentist, to cast elements of fixed and removable dental prostheses: precious metal bridges, bars, and posts; precious metal copings, pontics and bridges for porcelain-fused-to-metal restorations. For porcelain-fused-to-metal restorations it is intended by the manufacturer that only normal-fusing-temperature porcelain products be used with the Biogold Plus alloy. After fabrication and finishing the completed prosthesis is approved and placed in the patient's mouth by the dentist.
Device Description
Biogold Plus Dental Alloy
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K Number
K980597Device Name
CARRARA PDF, CARRARA H, CARRARA R
Manufacturer
Date Cleared
1998-03-09
(20 days)
Product Code
Regulation Number
872.3060Why did this record match?
Applicant Name (Manufacturer) :
EUROPEAN DENTAL IMPORTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Used by a dental lab technician, under the direction of an attending dentist, to cast elements of fixed and removable dental prostheses: precious metal inlays, onlays, and crowns; precious metal bridges, bars, posts, and attachments; precious metal copings and bridges for porcelain-fused-to-metal restorations. When used for porcelain-fused-to-metal restorations it is intended by the manufacturer that only Carrara Porcelain products be used with the Carrara alloys. After fabrication and finishing the completed prosthesis is approved and placed in the patient's mouth by the dentist.
Device Description
Not Found
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