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510(k) Data Aggregation
K Number
K013230Device Name
CERCON BASE
Manufacturer
Date Cleared
2001-10-25
(28 days)
Product Code
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
DEGUSSA - NEY DENTAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Cercon Base is a partially sintered yttria (yttrium oxide) stabilized zirconia (zirconium oxide) powder that is machined and then sintered to full density. It is designed for use as a substructure (framework) for single tooth or bridge type restorations. Applications include both anterior and posterior locations.
Device Description
Cercon Base is a partially sintered yttria (yttrium oxide) stabilized zirconia (zirconium oxide) powder that is machined and then sintered to full density.
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K Number
K011333Device Name
CERCON CERAM
Manufacturer
Date Cleared
2001-08-20
(110 days)
Product Code
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
DEGUSSA - NEY DENTAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K993514Device Name
DEFINITE
Manufacturer
Date Cleared
2000-02-24
(129 days)
Product Code
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
DEGUSSA - NEY DENTAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Definite® is a light cured composite intended to be used for all classes of restorations from class I to class V.
Device Description
Definite® is a light cured composite offered as a single paste system in compules. The system consists of the filling material Definite® and the self etching adhesive Etch&Prime® 3.0.
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K Number
K993897Device Name
CERGOGOLD
Manufacturer
Date Cleared
2000-01-10
(55 days)
Product Code
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
DEGUSSA - NEY DENTAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Ceramic Core This product 1 S used in the manufacture a "all-ceramic dental restorations, The product in the form of pellets and is processed with corrently marketed fornaces
Device Description
The product in the form of pellets
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K Number
K990629Device Name
SYMBIOCERAM
Manufacturer
Date Cleared
1999-03-19
(21 days)
Product Code
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
NEY DENTAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
DENTAL PORCELAIN DESIGNED FOR USE IN THE MANUFACTURE OF PORCELAIN FUSED TO METAL RESTORATION.
Device Description
Not Found
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K Number
K984427Device Name
EXCELSIOR PORCELAIN SYSTEM
Manufacturer
Date Cleared
1999-03-15
(94 days)
Product Code
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
NEY DENTAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
FOR USE IN THE MANUFACTURE OF PORCELAIN-FUSED-TO-METAL RESTORATIONS.
Device Description
Not Found
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