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Found 4 results
510(k) Data Aggregation
K Number
K002808Device Name
ANA 2000 NON GAMMA 2 EXTRA HIGH COPPER DENTAL ALLOY
Manufacturer
NORDISKA DENTAL AB
Date Cleared
2000-10-31
(53 days)
Product Code
EJJ
Regulation Number
872.3070Why did this record match?
Applicant Name (Manufacturer) :
NORDISKA DENTAL AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K002810Device Name
ANA 3000 SM NON GAMMA 2 MODIFIED SPHERICAL DENTAL ALLOY
Manufacturer
NORDISKA DENTAL AB
Date Cleared
2000-10-31
(53 days)
Product Code
EJJ
Regulation Number
872.3070Why did this record match?
Applicant Name (Manufacturer) :
NORDISKA DENTAL AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K002811Device Name
ANA 70 NON GAMMA 2 DISPERSED PHASE DENTAL ALLOY
Manufacturer
NORDISKA DENTAL AB
Date Cleared
2000-10-31
(53 days)
Product Code
EJJ
Regulation Number
872.3070Why did this record match?
Applicant Name (Manufacturer) :
NORDISKA DENTAL AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K992161Device Name
CERANA
Manufacturer
NORDISKA DENTAL AB
Date Cleared
1999-09-22
(89 days)
Product Code
EIH
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
NORDISKA DENTAL AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CERANA is designed to be used in class I primary and secondary caries/replacement of filling, class II primary and secondary caries and replacement of filling; restoration of ceramic crowns and repair of ceramic inlays; and class IV restorations.
Device Description
CERANA is an all-ceramic inlay that has the same translucency as enamel, can be finished and polished just like enamel and has the same natural color as enamel. The inlays are pre-etched, silanised and ready to use, when removed from the hygienic blister package.
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