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510(k) Data Aggregation
K Number
K133731Device Name
NOBELACTIVE WIDE PLATFORM (WP)
Manufacturer
NOBELBIOCARE AB
Date Cleared
2014-05-08
(153 days)
Product Code
DZE, NHA
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
NOBELBIOCARE AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Nobel Biocare's NobelActive implants are endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Nobel Biocare's NobelActive implants are indicated for single or multiple unit restorations in splinted or non-splinted applications. Nobel Biocare's NobelActive implants are intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Device Description
Nobel Biocare's NobelActive Wide Platform (WP) implants are threaded, root-form dental implants intended for use in the upper and/or lower jaw to support prosthetic devices, such as artificial teeth, in order to restore patient esthetics and chewing function to partially or fully edentulous patients. They are intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
The NobelActive Wide Platform (WP) implants share the same basic design principles as the existing NobelActive Internal Connection Implant. The Wide Platform (WP) implants are a bigger diameter implant extending the range of the existing NobelActive platforms. The Wide Platform is made of commercial pure titanium, is 5.5 mm in diameter, and available in lengths from 6.5 mm to 12.5 mm.
Healing and temporary abutments in both titanium/vanadium alloy and PEEK and definitive abutments made of titanium/vanadium alloy are available for the new WP platform. Titanium abutments may also be designed and made individually to fit the individual requirements for each patient using NobelBiocare's NobelProcera system.
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K Number
K093643Device Name
MULTI- UNIT ABUTMENTS FOR STRAUMANN AND ASTRA TECH IMPLANT SYSTEMS
Manufacturer
NOBELBIOCARE AB
Date Cleared
2010-06-24
(211 days)
Product Code
NHA
Regulation Number
872.3630Why did this record match?
Applicant Name (Manufacturer) :
NOBELBIOCARE AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Multi-Unit Abutments for Straumann and Astra Tech Implant Systems are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation.
Device Description
Nobel Biocare's Multi-Unit Abutments for Straumann and AstraTech Implant Systems are endosseous dental implant abutments. The Nobel Biocare Multi-Unit Abutments for Straumann and AstraTech Implant Systems attach directly to endosseous dental implants and provides a platform for restoration.
Nobel Biocare's Multi-Unit Abutments for Straumann and AstraTech Implant Systems are made entirely of titanium/vanadium alloy.
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