Search Results
Found 7 results
510(k) Data Aggregation
K Number
K153645Device Name
VITA ENAMIC Implant Solutions (IS)
Manufacturer
VITA ZAHNFABRIK H. RAUTER GMBH CO.
Date Cleared
2016-06-30
(192 days)
Product Code
NHA
Regulation Number
872.3630Why did this record match?
Applicant Name (Manufacturer) :
**VITA ZAHNFABRIK H. RAUTER GMBH **CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
VITA ENAMIC Implant Solutions is indicated for use as a component of a two-piece abutment system, consisting of a tibase component, and a mesostructure or abutment crown. VITA ENAMIC Implant Solutions is intended for use in partially or fully edentulous mandible or maxillae for fabrication of permanent, anterior or posterior, single unit CAD/CAM abutments. VITA ENAMIC Implant Solutions is indicated for use in conjunction with the CAD/CAM component of the Sirona Dental CAD/CAM system and the following Tibase abutments and implant bodies: (See Table 1 in document for list of compatible Ti Base/Implant Systems).
Device Description
VITA ENAMIC Implant Solutions (IS) is a hybrid ceramic CAD/CAM block, consisting of ~86% (by weight) feldspar ceramic and ~14% polymer. The VITA ENAMIC Implant Solutions is milled then bonded to a titanium (Ti) base for a two-element solution with mesostructure or a single-element solution with abutment crown. The compatible Ti bases to VITA ENAMIC IS block interface size and CAD/CAM system are as follows: Ti Base: Sirona TiBase (K111421), CAD/CAM System: Sirona software – inlab 15.0 and above, Sirona software – CEREC 4.4 and above, Titanium Bases: Compatible titanium bases are shown in Table 1. VITA ENAMIC IS is offered in a block form, with a mandrel attachment, to permit securing it into a CAD/CAM machine for milling into its final form. The VITA ENAMIC IS blocks have a pre-drilled hole compatible with Sirona TiBase (K111421) to allow the mesostructure or abutment crown bonded to a titanium base to be connected to the implant. VITA ENAMIC IS blocks are identical to VITA ENAMIC blocks (K122269) in geometry, with the exception of a pre-drilled hole.
Ask a Question
K Number
K152373Device Name
VITA VM LC Flow
Manufacturer
VITA ZAHNFABRIK H. RAUTER GMBH & CO.
Date Cleared
2015-12-30
(131 days)
Product Code
EBF
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
**VITA ZAHNFABRIK H. RAUTER GMBH **& CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
- Full and partial veneering of metal frameworks: crowns, bridges, telescopic crowns, implant superstructure
- Individualization of and layering on VITA ENAMIC®
- Layering-over long-term temporaries made from VITA CAD-Temp®
- Individualization of acrylic teeth
- Reproduction of gingival components
- Metal-free crowns and three-unit anterior bridges as long-term temporary restorations
- Veneering of removable and partially removable dentures (according to the manufacturer's information)
- Inlays
- Veneers
Device Description
VITA VM LC Flow is a light-cured microparticle indirect composite material for fixed and removable restorations for extraoral fabrication.
Ask a Question
K Number
K132070Device Name
VITA SUPRINITY(R)
Manufacturer
VITA ZAHNFABRIK H. RAUTER GMBH & CO.
Date Cleared
2014-01-31
(212 days)
Product Code
EIH
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
**VITA ZAHNFABRIK H. RAUTER GMBH **& CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
K Number
K122269Device Name
ENAMIC
Manufacturer
VITA ZAHNFABRIK H. RAUTER GMBH & CO.
Date Cleared
2012-12-13
(136 days)
Product Code
EIH, EBF
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
**VITA ZAHNFABRIK H. RAUTER GMBH **& CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Enamic® is indicated for use as a dental restoration including inlays, onlays, veneers, and crowns.
Device Description
The Vita Enamic® block consists of interpenetrating networks of ceramic and polymer material to form a solid block of material. The unique marriage of the two materials creates a dual-network hybrid, which lends the positive physical properties of each individual material to the other. This results in a material with significantly lower brittleness of a pure ceramic and better abrasion behavior than a pure resin, (similar to natural enamel). The material is milled in a dental CAD/CAM machine into its restorative form.
Ask a Question
K Number
K102128Device Name
VITABLOCS
Manufacturer
VITA ZAHNFABRIK H. RAUTER GMBH & CO.
Date Cleared
2010-08-11
(13 days)
Product Code
EIH
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
**VITA ZAHNFABRIK H. RAUTER GMBH **& CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Vitablocs® are indicated for use as a dental restoration including inlays, onlays, veneers, crowns and bridges.
Device Description
Not Found
Ask a Question
K Number
K093446Device Name
VITA VMK MASTER
Manufacturer
VITA ZAHNFABRIK H. RAUTER GMBH & CO. KG.
Date Cleared
2009-12-03
(28 days)
Product Code
EIH
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
**VITA ZAHNFABRIK H. RAUTER GMBH **& CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Vita VMK Master® is indicated for use as part of a dental restoration in the form of a ceramic veneering material (full or partial) of a metal substructure.
Device Description
Not Found
Ask a Question
K Number
K090644Device Name
VITABLOCS, MODEL VX55-****
Manufacturer
VITA ZAHNFABRIK H. RAUTER GMBH & CO.
Date Cleared
2009-03-31
(21 days)
Product Code
EIH
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
**VITA ZAHNFABRIK H. RAUTER GMBH **& CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Vitablocs® are indicated for use as a dental restoration including inlays, onlays, veneers and crowns.
Device Description
Not Found
Ask a Question
Page 1 of 1