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Found 8 results
510(k) Data Aggregation
K Number
K110058Device Name
BPA-FREE PIT AND FISSURE SEALANT
Manufacturer
NOVOCOL INC. DBA SEPTODONT AND CONFI-DENTAL PRODUC
Date Cleared
2011-03-31
(80 days)
Product Code
EBC
Regulation Number
872.3765Why did this record match?
Applicant Name (Manufacturer) :
DBA SEPTODONT AND CONFI-DENTAL PRODUC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
"BPA-Free Pit and Fissure Sealant" is indicated for the covering and sealing of pits and fissures in the occlusal surfaces of posterior teeth to aid in the resistance to caries in those surfaces.
Device Description
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K Number
K101540Device Name
GRANITEC DUAL-CURE CORE BUILD-UP, N'DURANCE DIMER CORE
Manufacturer
NOVOCOL INC. DBA SEPTODONT AND CONFI-DENTAL PRODUC
Date Cleared
2010-10-29
(148 days)
Product Code
EBF
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
DBA SEPTODONT AND CONFI-DENTAL PRODUC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Granitec® Dual-Cure Core Build-Up is indicated for direct build-up of the crowns of teeth that have been badly broken down and are in need of a prosthetic crown in order to regain function. It is especially indicated for use under esthetic full porcelain and composite crowns, onlays and inlays where the underlying tooth structure and core restoration will show through the esthetic veneer. It can be used on vital or de-vital, endodontically treated teeth. It may be used with pins and posts and should be bonded to the tooth with a bonding agent.
N'Durance Dimer Core is indicated for direct build-up of the crowns of teeth that have been badly broken down and are in need of a prosthetic crown in order to regain function. It is especially indicated for use under esthetic full porcelain and composite crowns, onlays and inlays where the underlying tooth structure an d core restoration will show through the esthetic veneer. It can be used on vital or de-vital, endodontically treated teeth. It may be used with pins and posts and should be bonded to the tooth with a bonding agent.
Device Description
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K Number
K042212Device Name
IMPLANTMASTER
Manufacturer
I-DENT
Date Cleared
2004-10-21
(66 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
I-DENT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ImplantMaster system is indicated for use as a front-end software interface for the transfer of imaging information from a medical scanner such as a CT scanner. It is also indicated for use as a planning and simulation software for use by qualified dental professionals to aid them in the placement of dental implants and surgical treatment. ImplantMaster processes the dental professional's input information and the result is used as an input data for CAD or Rapid Prototyping System.
Device Description
The ImplantMaster system is a software interface used for the transfer of imaging information from a medical scanner such as a CT scanner, processing it and planning dental implant placement and surgical treatment. The ImplantMaster processes output result is used as an input data for CAD or Rapid Prototyping System.
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K Number
K030807Device Name
CARIES INDICATOR
Manufacturer
CONFI-DENTAL PRODUCTS CO.
Date Cleared
2003-06-09
(88 days)
Product Code
LFC
Regulation Number
872.1740Why did this record match?
Applicant Name (Manufacturer) :
CONFI-DENTAL PRODUCTS CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Caries Indicator is indicated for the following applications: Designed to be used to help identify caries in dentin.
Device Description
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K Number
K030743Device Name
ETCHANT 40%
Manufacturer
CONFI-DENTAL PRODUCTS CO.
Date Cleared
2003-05-09
(60 days)
Product Code
KLE
Regulation Number
872.3200Why did this record match?
Applicant Name (Manufacturer) :
CONFI-DENTAL PRODUCTS CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Etchant 40% is indicated for initiation of the bonding sequence for bonding restorative materials to enamel and/or dentin.
Device Description
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K Number
K955328Device Name
CONFI-BOND
Manufacturer
CONFI-DENTAL PRODUCTS CO.
Date Cleared
1996-03-28
(129 days)
Product Code
KLE
Regulation Number
872.3200Why did this record match?
Applicant Name (Manufacturer) :
CONFI-DENTAL PRODUCTS CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K955329Device Name
RESILIENCE M5 PROTECTION PLUS
Manufacturer
CONFI-DENTAL PRODUCTS CO.
Date Cleared
1996-03-28
(129 days)
Product Code
DYH
Regulation Number
872.3750Why did this record match?
Applicant Name (Manufacturer) :
CONFI-DENTAL PRODUCTS CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K954988Device Name
CRYSTALLESSENCE
Manufacturer
CONFI-DENTAL PRODUCTS CO.
Date Cleared
1996-03-08
(129 days)
Product Code
EBF
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
CONFI-DENTAL PRODUCTS CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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