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Found 21 results
510(k) Data Aggregation
K Number
K053114Device Name
SILVERFIL
Manufacturer
DUNIA PERWIRA MANUFACTURING SDN. BHD.
Date Cleared
2005-11-15
(8 days)
Product Code
EJJ
Regulation Number
872.3070Why did this record match?
Product Code :
EJJ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Silverfil amalgam is used by dental professionals to fill tooth cavities. It is used in the same way as other amalgams used in the world today. Its usage and handling techniques are the same as other amalgams.
Device Description
Not Found
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K Number
K051010Device Name
SECURALLOY, SEPTALLOY NG 50 AND SEPTALLOY NG 70
Manufacturer
SEPTODONT
Date Cleared
2005-05-02
(11 days)
Product Code
EJJ
Regulation Number
872.3070Why did this record match?
Product Code :
EJJ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use for SECURALLOY dental amalgam is the filling cavities in posterior teeth (class I and class II restorations) and core build-up.
The intended use for SEPTALLOY NG 70 dental amalgam is the filling cavities in posterior teeth (class I and class II restorations) and core build-up.
The intended use for SEPTALLOY NG 50 dental amalgam is the filling cavities in posterior teeth (class I and class II restorations) and core build-up.
Device Description
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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?
Product Code :
EJJ
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
K032152Device Name
BENCO ADMIX
Manufacturer
SOUTHERN DENTAL INDUSTRIES, INC.
Date Cleared
2003-08-06
(70 days)
Product Code
EJJ
Regulation Number
872.3070Why did this record match?
Product Code :
EJJ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Silver based alloy dental restorative used in all classes of restorations.
Device Description
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K Number
K031658Device Name
BENCO SPHERICAL
Manufacturer
SOUTHERN DENTAL INDUSTRIES, INC.
Date Cleared
2003-07-29
(62 days)
Product Code
EJJ
Regulation Number
872.3070Why did this record match?
Product Code :
EJJ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Silver based alloy dental restorative used in all classes of restorations.
Device Description
Not Found
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K Number
K020452Device Name
HIGH SILVER CONVENTIONAL
Manufacturer
AB ARDENT
Date Cleared
2002-05-07
(85 days)
Product Code
EJJ
Regulation Number
872.3070Why did this record match?
Product Code :
EJJ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
HIGH SILVER CONVENTIONAL is to be used as a filling material for restoring function to teeth which have lost portions to caries:
Direct, fixed restorations, placed by the dentist after removal of carious tissue.
Single surface cavities such as Class I
Two surface cavities such as MO, DO, FO, LO
Three surface cavities such as MOD, FOD.
Pinned onlays and half crowns.
Core build-ups for cast half and full crowns.
For use only by dental professional such as DDS or DMD. Not for use by general public or OTC.
Device Description
HIGH SILVER CONVENTIONAL
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K Number
K011801Device Name
FUTURA TOPCAP NON GAMMA-2
Manufacturer
AB ARDENT
Date Cleared
2001-08-16
(69 days)
Product Code
EJJ
Regulation Number
872.3070Why did this record match?
Product Code :
EJJ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
FUTURA TOPCAP non gamma-2 is to be used as a filling material for restoring function to teeth which have lost portions to caries:
Direct, fixed restorations, placed by the dentist after removal of carious tissue.
Single surface cavities such as Class I
Two surface cavities such as MO, DO, FO, LO
Three surface cavities such as MOD, FOD.
Pinned onlays and half crowns.
Core build-ups for cast half and full crowns.
For use only by dental professional such as DDS or DMD. Not for use by general public or OTC.
Labels will bear this caution.
Device Description
Not Found
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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?
Product Code :
EJJ
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?
Product Code :
EJJ
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?
Product Code :
EJJ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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