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510(k) Data Aggregation
K Number
K121735Device Name
FIBER DISK AND BLOCK PERMANENT, TRINIA
Manufacturer
BIOLOREN SRL
Date Cleared
2013-02-21
(253 days)
Product Code
EBF
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
BIOLOREN SRL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Fiber Disks and Blocks are milling blanks composed of a multi-directional interlacing of fiberglass and resin in several layers. They are intended to be used solely by dental technicians and dentists for making only copings, substructures or frameworks for permanent and transitional anterior or posterior crowns, bridgework and substructures that can be for either cemented or uncemented restorations e.g., telescopic restorations.
Device Description
Fiber Disks and Blocks are milling blanks composed of a multi-directional interlacing of fiberglass and resin in several layers.
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K Number
K112186Device Name
FIBER DISK AND BLOCK
Manufacturer
BIOLOREN SRL
Date Cleared
2011-11-08
(102 days)
Product Code
EBG
Regulation Number
872.3770Why did this record match?
Applicant Name (Manufacturer) :
BIOLOREN SRL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Fiber Disks and Blocks are milling blanks composed of a multidirectional interlacing of fiberglass and resin in several layers. They are intended to be used solely by professional dental technicians or dentists for making long-term temporary crowns, bridgework for one or two pontics, single tooth restorations, frameworks for particular patients, and substructures for anterior and posterior regions.
Device Description
Fiber Disks and Blocks are milling blanks composed of a multidirectional interlacing of fiberglass and resin in several layers.
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