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Found 14 results
510(k) Data Aggregation
K Number
K063768Device Name
TITANIUM SCALLOPED ABUTMENT
Manufacturer
VIDENT
Date Cleared
2007-06-27
(189 days)
Product Code
NHA
Regulation Number
872.3630Why did this record match?
Applicant Name (Manufacturer) :
VIDENT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Titanium Scalloped abutments are designed for use with Nobel Biocare® Brånemark™ external hex, 31™ external hex and Zimmer® internal hex dental implant systems. The abutments, which do not osseointegrate, are to be seated directly on top of the implant body. The abutments form the substructure of the restored prosthesis cemented onto the abutment. The abutments are indicated for full arch or partially endentulous patient restoration including single implant restorations,
Device Description
Titanium Scalloped Abutment
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K Number
K060441Device Name
VITA VM 7, MODEL NX77 XXXX, NX78XXXX, NX79 XXXX; VITA VM 8, MODEL VX60 XXXX, VX61 XXXX, VX62 XXXX; VITA VM 9, MODEL NX98
Manufacturer
VIDENT
Date Cleared
2006-04-27
(65 days)
Product Code
EIH
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
VIDENT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Vita VM® porcelains are indicated for use as a veneering material for fixed prosthesis in crowns, bridges, and dental implant abutments. These devices are used in prosthetic dentistry by forming a porcelain veneer on to a ceramic or metal substructure into the shape of a dental crown.
Device Description
Not Found
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K Number
K052710Device Name
VITA VM7, MODEL NX77 XXXX, NX78XXXX, NX79 XXXX; VITA VM 8, MODEL VX60 XXXX, VX61 XXXX, VX62 XXXX; VITA VM 9,
Manufacturer
VIDENT
Date Cleared
2006-01-13
(106 days)
Product Code
EIH
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
VIDENT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Vita VM® porcelains are indicated for use as a veneering material for fixed prosthesis in crowns, bridges, and dental implant abutments. These devices are used in prosthetic dentistry by forming a porcelain veneer on to a ceramic or metal substructure into the shape of a dental crown.
For use by or on the order of a dental professional such as DDS or DMD. Not for use by the general public or OTC.
Device Description
Vita VM® porcelains are indicated for use as a veneering material for fixed prosthesis in crowns, bridges, and dental implant abutments. These devices are used in prosthetic dentistry by forming a porcelain veneer on to a ceramic or metal substructure into the shape of a dental crown.
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K Number
K052130Device Name
VITA IN-CERAM 2000 AL CUBES FOR INLAB, MODELS AL20/AL40
Manufacturer
VIDENT
Date Cleared
2005-08-15
(10 days)
Product Code
EIH
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
VIDENT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
In-Ceram® 2000 AL CUBES for inLab® are indicated for use as a substructure for porcelain fused ceramic fixed dental restorations; for single unit anterior or posterior crowns and 3 unit anterior bridges.
Substructures of AL Cubes for Cerec are machined using the Cerec 2, Cerec 3 and InLab cad/cam systems.
For use by or on the order of a dental professional such as DDS or DMD. Not for use by the general public or OTC.
Device Description
Vita In-Ceram® 2000 AL Cubes for inLab® are indicated for use as a substructure for porcelain fused ceramic fixed dental restorations; for single unit anterior or posterior crowns and 3 unit anterior bridges. Substructures of AL Cubes for Cerec are machined using the Cerec 2, Cerec 3 and InLab cad/cam systems.
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K Number
K050362Device Name
VITA PM 7 (20 GRAM BOTTLES), VITA PM 7 (50 GRAM BOTTLES)
Manufacturer
VIDENT
Date Cleared
2005-03-15
(29 days)
Product Code
EIH
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
VIDENT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Vita PM7 pressable ceramic is to be used for the fabrication of
- Single and multi-surface inlays O
- Onlays o
- Veneers O
- Partial crowns ্
- Anterior crowns 0
- Premolar crowns o
Also for oxide-ceramic crown and bridge substructures to be veneered with conventional porcelain.
For use by or on the order of a dental professional such as DDS or DMD. Not for use by the general public or OTC.
Device Description
Not Found
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K Number
K022996Device Name
VITA IN-CERAM YZ CUBES FOR CEREC
Manufacturer
VIDENT
Date Cleared
2002-10-09
(30 days)
Product Code
EIH
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
VIDENT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Vita In-Ciram YZ® Cubes for Cerec® is indicated for use as a substructure for porcelain fused ceramic fixed dental restorations; namely crowns and bridges. Sub tructures of YZ® Cubes for Cerec® are machined using the Cerec 2, Cerec 3 and InLat; systems.
Device Description
Not Found
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K Number
K012473Device Name
VIDENT HEXTOP, SYNOCTA IN-CERAM BLANK/COPING MANUFACTURED BY VIDENT
Manufacturer
VIDENT
Date Cleared
2002-09-11
(405 days)
Product Code
DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
VIDENT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Ceramic hextop abutments are designed for use with commercially available osseointegrated dental implant systems. The abutments, which do not osseointegrate, are to be seated directly on top of the implant body. The abutments form the substructure of the restored prosthesis.
The ITI® ceramic coping is intended to be seated on the implant/abutment complex and serve as a base for the prosthetic reconstruction. The prefabricated coping provides a machined inner surface for mating with the abutment and implant, while the outer surface can be adapted to the individual restoration.
Device Description
Not Found
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K Number
K000597Device Name
VITA RESPONSE
Manufacturer
VIDENT
Date Cleared
2000-05-17
(85 days)
Product Code
EIH
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
VIDENT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K990367Device Name
PDQ AND PDQ-TI ABUTMENT
Manufacturer
VIDENT
Date Cleared
1999-04-21
(75 days)
Product Code
DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
VIDENT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
PDQ and PDQ-Ti abutments are designed for use with commercially available osseointegrated dental implant systems. The abutments, which do not osseointegrate, are to be seated directly on top of the implant body. The abutments form the substructure of the restored prosthesis.
Device Description
PDQ and PDQ-Ti Abutments
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K Number
K984198Device Name
WIDE BODY ABUTMENTS
Manufacturer
VIDENT
Date Cleared
1999-02-18
(86 days)
Product Code
DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
VIDENT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Wide Body abutments are designed for use with commercially available osseointegrated dental implant systems. The abutments which do not osseointegrate are to be seated directly on tope of the implant body. The abutments form the substructure of the restored prosthesis.
Device Description
Wide Body Abutments
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