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510(k) Data Aggregation
K Number
K033446Device Name
APEX93, APEX87, APEX84, APEX85, APEX77, E-SARANG 88 AND E-SARANG 82
Manufacturer
WE DONG MYUNG DENTAL INDUSTRIAL CO., LTD.
Date Cleared
2003-11-13
(15 days)
Product Code
EJT
Regulation Number
872.3060Why did this record match?
Applicant Name (Manufacturer) :
WE DONG MYUNG DENTAL INDUSTRIAL CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Reconstruction of porcelain-to-metal dental restorations.
Device Description
Apex 93, Apex87, Apex85, Apex77, e-Sarang 88 and e-Sarang 82 are dental gold alloys for the fabrication of Porcelain-Fused-to-Metal Crowns, Bridges, and implant-supported prosthesis substructures.
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K Number
K033434Device Name
BESTALOY
Manufacturer
WE DONG MYUNG DENTAL INDUSTRIAL CO., LTD.
Date Cleared
2003-11-12
(15 days)
Product Code
EJJ
Regulation Number
872.3070Why did this record match?
Applicant Name (Manufacturer) :
WE DONG MYUNG DENTAL INDUSTRIAL CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This is a dental amalgam for the filling of tooth cavities of Black's Classes I and II.
Device Description
Bestaloy is used as a filling material for restoring function to teeth that have lost portions to caries.
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K Number
K033435Device Name
E-SARANG 86, DM78, DM55
Manufacturer
WE DONG MYUNG DENTAL INDUSTRIAL CO., LTD.
Date Cleared
2003-11-12
(15 days)
Product Code
EJT
Regulation Number
872.3060Why did this record match?
Applicant Name (Manufacturer) :
WE DONG MYUNG DENTAL INDUSTRIAL CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Reconstruction of dental restorations.
e-Sarang 86: Inlays for non stress-bearing areas.
DM-78: full crowns, 3/4 crowns, and short-span fixed partial dentures.
DM-55: full crowns, long-span fixed partial dentures, and removable partial dentures
Device Description
e-Sarang 86, DM-78 and DM-55 are dental casting gold alloy for the fabrication of inlay/onlays, crowns, short span bridges, long span bridges and removable partials.
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K Number
K030206Device Name
APEX 90
Manufacturer
WE DONG MYUNG DENTAL INDUSTRIAL CO., LTD.
Date Cleared
2003-01-29
(8 days)
Product Code
EJT
Regulation Number
872.3060Why did this record match?
Applicant Name (Manufacturer) :
WE DONG MYUNG DENTAL INDUSTRIAL CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Reconstruction of porcelain-to-metal dental restorations/reconstruction of dental restorations.
Device Description
Apex90 is a dental gold alloy for the fabrication of Porcelain-Fused-to-Metal Dental Crowns, Bridges, and implant-supported prosthesis substructures, which is composed of 98% of gold and platinum bearing gold color
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