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510(k) Data Aggregation
K Number
K153753Device Name
TelioCAD Multi
Manufacturer
IVOCLAR VIVADENT, INC.
Date Cleared
2016-04-12
(105 days)
Product Code
EBG
Regulation Number
872.3770Why did this record match?
Applicant Name (Manufacturer) :
IVOCLAR VIVADENT, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For manufacturing by a CAD/CAM System:
- Provisional anterior and posterior crowns with a maximum wear period of up to 12 months
- Provisional anterior and posterior bridges with up to two adjacent pontics for a maximum wear period of up to 12 months
- Provisional inlay and onlays
Device Description
Telio CAD Multi are PMMA discs used for fabrication of long-term temporaries by means of CAD/CAM technology. The PMMA discs have a Long-term (12-month) wear period and durable shade stability with lifelike layered appearance. The device is available in 8 shades (BL2, A1, A2, A3, A3.5, A4, B1 and B2) and 4 thicknesses 12mm, 16mm, 20mm and 25mm. They are the standard 98.5 mm in diameter to permit use with the Wieland Select Milling equipment or other equipment which accepts 98.5 mm discs. The material exhibits high homogeneity due to industrial manufacturing process and temporaries can be easily reproduced using the CAD/CAM Technology. The device is contraindicated for use in permanent restorations and bridge designs involving more than two adjacent pontics. The device should not be used in patients with para-functional habits, ex. Bruxism or patients known to be allergic to the ingredients.
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K Number
K143575Device Name
Accu-Dent XD Tray, Accu-Dent XD Syringe
Manufacturer
IVOCLAR VIVADENT, INC.
Date Cleared
2015-04-03
(107 days)
Product Code
ELW
Regulation Number
872.3660Why did this record match?
Applicant Name (Manufacturer) :
IVOCLAR VIVADENT, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Accu-Dent XD impression materials are recommended for used to create highly detailed impressions of the hard and soft tissues of the oral cavity includin the following list of indications:
- Complete and partial denture impressions ●
- Opposing models for fixed and removable prosthesis ●
- o Study Model
- Temporary crown & Bridge impressions
- Whitening Trays ●
- Mouth Guards ●
- Orthodontic Impressions o
Device Description
Accu-Dent XD is a two-part Alginate impression system intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide impressions models for study and for production of restorative prosthetic devices, such as full and partial dentures.
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K Number
K132984Device Name
SR VIVODENT S, SR ORTHOTYP S, SR ORTHOLINGUAL S
Manufacturer
IVOCLAR VIVADENT, INC.
Date Cleared
2014-01-14
(112 days)
Product Code
ELM
Regulation Number
872.3590Why did this record match?
Applicant Name (Manufacturer) :
IVOCLAR VIVADENT, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Preformed denture teeth used for total and partial dentures and implant-supported removable prostheses.
Device Description
Preformed denture teeth used for total and partial dentures and implant-supported removable prostheses.
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K Number
K111958Device Name
TETRIC EVOCERAM BULK FILL
Manufacturer
IVOCLAR VIVADENT, INC.
Date Cleared
2011-10-14
(95 days)
Product Code
EBF
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
IVOCLAR VIVADENT, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Restoration of Deciduous teeth Restorations in the posterior region (Classes I and ii) Class V restorations (cervical caries, root erosion, wedge-shaped defects) Extended fissure sealing in molars and premolars
Device Description
Not Found
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K Number
K110756Device Name
BLUEPHASE STYLE
Manufacturer
IVOCLAR VIVADENT, INC.
Date Cleared
2011-08-29
(164 days)
Product Code
EBZ
Regulation Number
872.6070Why did this record match?
Applicant Name (Manufacturer) :
IVOCLAR VIVADENT, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For light curing polymerization of light-curing dental materials curing in the wavelength range of 385-515 nm. These materials include restoratives, bonding agents/adhesives, bases, liners, fissure sealants, temporaries, as well as luting mateirals for brackets and indirect restorations, such as ceramic inlays.
Device Description
Not Found
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K Number
K103556Device Name
IPS E.MAX CAD CRYSTALL / CONNECT AND IPS E.MAX CAD CRYSTAL / ADD-ON CONNECT (FOR CAD-ON TECHNIQUE)
Manufacturer
IVOCLAR VIVADENT, INC.
Date Cleared
2011-04-13
(132 days)
Product Code
EIH
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
IVOCLAR VIVADENT, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
IPS e.max® CAD Crystall/Connect and IPS e.max® CAD Crystall/Add-On Connect (for CAD-On Technique) is intended to be used for the fabrication of:
Crowns
Splinted crowns
3-4 unit bridges
Crown, splinted crown or 3-4 unit bridge placed on top of an implant abutment ._
Device Description
Not Found
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K Number
K103528Device Name
IPS EMPRESS DIRECT FLOW
Manufacturer
IVOCLAR VIVADENT, INC.
Date Cleared
2011-02-25
(87 days)
Product Code
EBF, EBC, EBD
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
IVOCLAR VIVADENT, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
As an intermediate or covering layer in the fabrication of esthetically demanding composite restorations
Repair of composite restorations (in particular filling of voids, levelling out of porosities and minor chips)
As a thin (< 0.5mm) initial layer under Class I and II restorations
Small restorations of all types
Extended fissure sealing
Splinting of mobile teeth
Blocking out of undercuts
Repair of composite and ceramic veneers
Device Description
Not Found
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K Number
K103391Device Name
IVOBASE HYBRID, IVOBASE HIGH IMPACT
Manufacturer
IVOCLAR VIVADENT, INC.
Date Cleared
2011-02-17
(90 days)
Product Code
EBI
Regulation Number
872.3760Why did this record match?
Applicant Name (Manufacturer) :
IVOCLAR VIVADENT, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
IvoBase Hybrid and IvoBase High Impact are intended for the fabrication of PMMA based acrylic dental prosthesis including but not limited to partial and full dentures.
Device Description
Not Found
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K Number
K103379Device Name
TELIO CS INLAY & TELIO CS ONLAY
Manufacturer
IVOCLAR VIVADENT, INC.
Date Cleared
2011-02-14
(89 days)
Product Code
EBG
Regulation Number
872.3770Why did this record match?
Applicant Name (Manufacturer) :
IVOCLAR VIVADENT, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Telio CS Inlay:
Temporization of deep inlay preparations with paralle! walls
Sealing of implant screw access holes
Relining of pre-fabricated, temporary crowns and bridges made of polycarbonate or methacrylates.
Telio CS Onlay:
Temporization of large, shallow cavities (onlay preparations).
Device Description
Not Found
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K Number
K093708Device Name
TELIO CAD
Manufacturer
IVOCLAR VIVADENT, INC.
Date Cleared
2010-03-10
(98 days)
Product Code
EBG
Regulation Number
872.3770Why did this record match?
Applicant Name (Manufacturer) :
IVOCLAR VIVADENT, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For the fabrication of temporary crowns and bridges using the CAD/CAM technology until the permanent restoration can be delivered.
Device Description
Not Found
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