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510(k) Data Aggregation
K Number
K143524Device Name
Fiber Disks and Blocks (TRINIA)
Manufacturer
Bicon, LLC
Date Cleared
2015-06-02
(172 days)
Product Code
EBF
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
Bicon, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Fiber Disks and Blocks (TRINIA) 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 copings, substructures, or frameworks for permanent and transitional anterior or posterior crowns, and substructures that can be for either cemented or uncemented restorations (e.g. telescopic restorations).
Device Description
Fiber Disks and Blocks (TRINIA) are milling blanks composed of a multi-directional interlacing of fiberglass and resin in several layers.
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K Number
K133608Device Name
TRINIA
Manufacturer
BICON, LLC
Date Cleared
2014-03-14
(109 days)
Product Code
EBF, EBG, EBI
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
BICON, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Fiber Disks and Blocks (TRINIA) 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 copings, substructures, removable dentures, 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
TRINIA is a fiber machining disk block. It is made of layers of glass fibers kept together by epoxy resin. TRINIA products are designed for the manufacturing of non-metallic dental appliances. The dental appliance is machined either by a CAD/CAM machine or by using the copying technique. TRINIA already possesses the mechanical characteristics needed for producing these dental appliances; no curing is necessary at the dental lab to make the product function properly.
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K Number
K101849Device Name
BICON DENTAL IMPLANT SYSTEM 3.0MM BICON DENTAL IMPLANT
Manufacturer
BICON, LLC
Date Cleared
2010-10-01
(92 days)
Product Code
DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
BICON, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 3.0 mm Bicon implants are designed for use in edentulous sites in the mandible or maxilla for support of a complete denture prosthesis, a terminal or intermediate abutment for fixed bridgework, support of the res, or as a single tooth replacement. The device may be used equally well in a single-stage or two-stage surgical procedure. It is indicated for immediate implantation in extraction sites or implantation in partially healed or completely healed alveolar ridge situations. When a one-stage implantationoroach is applied, the implant may be immediately loaded when good primary stability is achieved and the functional load is appropriate. The 3.0 Bicon implants shall be used only to replace maxillary lateral incisors and mandibular lateral and central incisors.
Device Description
Not Found
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K Number
K092035Device Name
BICON IMPLANTS WITH A 2.5MM INTERNAL CONNECTION
Manufacturer
BICON, LLC
Date Cleared
2009-10-15
(101 days)
Product Code
DZE, NHA
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
BICON, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Bicon implant is designed for use in edentulous sites in the mandible or maxilla for support of a complete denture prosthesis, a final or intermediate abutment for fixed bridgework or for partial dentures, or as a single tooth replacement.
Device Description
Not Found
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K Number
K073368Device Name
5.0 X 5.0MM DENTAL IMPLANT AND 6.0 X 5.0 DENTAL IMPLANT
Manufacturer
BICON, LLC
Date Cleared
2008-10-10
(315 days)
Product Code
DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
BICON, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 5.0 x 5.0mm and the 6.0 x 5.0mm implants are designed as a one stage or two stage surgical procedure implant for use in edentulous sites in the mandible or maxilla for support of a complete denture prosthesis, a terminal or intermediate abutment for fixed bridgework, partial dentures, or a single tooth replacement
Device Description
Not Found
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