Search Results
Found 2 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) :
NOVOCOL INC. 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
Not Found
Ask a Question
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) :
NOVOCOL INC. 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
Not Found
Ask a Question
Page 1 of 1