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510(k) Data Aggregation
K Number
K132749Device Name
NOBELPROCERA OVERDENTURE BAR
Manufacturer
NOBEL BIOCARE USA, LLC
Date Cleared
2014-07-24
(324 days)
Product Code
NHA
Regulation Number
872.3630Why did this record match?
Applicant Name (Manufacturer) :
NOBEL BIOCARE USA, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NobelProcera Overdenture Bar is indicated for use as an overdenture bar that attaches to implants or abutments in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function.
Device Description
NobelProcera Overdenture Bars are computer aided design (CAM) precision milled, individually designed Superstructures manufactured for each patient. The NobelProcera Overdenture Bar provides retention and support for a removable or fixed denture made of standard laboratory dental materials such as resin composite or porcelain veneer.
The Superstructures can be either Fixed Shaped Bars such as Dolder, Hader, Round, or Free Form Shaped Bars such as Free Form Milled, Montreal, Paris, Wrap-around; or a combination of shapes. The Overdenture Bar shapes and design parameters remain unchanged from the predicate device, Procera Implant Bridge Overdenture (K090069). Additionally, the Superstructure can also be designed per specific prescription order by qualified health care professionals.
The Superstructure is a multiple unit restoration for fixed or removeable dental prosthetic framework milled from one solid piece of material. The NobelProcera Overdenture Bar accommodates commercially available denture attachments for removable dental prosthesis, or retention elements for fixed dental prosthesis.
The many abutment and implant interfaces that can be used in the Superstructure are precision milled and are an integral part of the Overdenture Bar.
The NobelProcera Overdenture Bar is packaged as non-sterile, and delivered to a dental laboratory for completion. Once received at the laboratory, the NobelProcera Overdenture Bar is matched to a denture for final placement.
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K Number
K132746Device Name
NOBELPROCERA ANGULATED SCREW CHANNEL ABUTMENT CONICAL CONNECTION
Manufacturer
NOBEL BIOCARE USA, LLC
Date Cleared
2014-01-30
(149 days)
Product Code
NHA
Regulation Number
872.3630Why did this record match?
Applicant Name (Manufacturer) :
NOBEL BIOCARE USA, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K083100Device Name
GOLDADAPT NON-ENGAGING NOBELACTIVE NP & RP, GOLDADAPT ENGAGING NOBELACTIVE NP & RP
Manufacturer
NOBEL BIOCARE USA, LLC
Date Cleared
2008-11-19
(30 days)
Product Code
NHA, DZE
Regulation Number
872.3630Why did this record match?
Applicant Name (Manufacturer) :
NOBEL BIOCARE USA, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
NobelActive GoldAdapt Abutment is a pre-manufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.
Nobel Biocare's NobelActive implants are endosseous implant 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 nonsplinted applications. Nobel Biocare's NobelActive implants may be placed immediately and put into immediate function provided that initial stability requirements detailed in the manual are satisfied.
Device Description
The NobelActive GoldAdapt Abutment is an endosseous dental implant abutment intended to be used with the NobelActive implant system. The NobelActive GoldAdapt is made of gold alloy and comes in engaging and non-engaging styles.
NobelActive Internal Connection 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.
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K Number
K043312Device Name
NOBELRONDO DENTAL CERAMIC - ZIRCONIA
Manufacturer
NOBEL BIOCARE USA, LLC
Date Cleared
2005-02-01
(62 days)
Product Code
EIH
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
NOBEL BIOCARE USA, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
NobelRondo Dental Ceramic - Zirconia is a ceramic material intended for veneering substructures such as single crowns, multiple frameworks or abutments made from zirconia.
Device Description
NobelRondo Dental Ceramic – Zirconia is dental porcelain intended for use in the construction of zirconium oxide ceramic prosthetics. NobelRondo consists of sixteen (16) porcelain shades corresponding to Vita shades A0-C3 and various shade modifiers. The shade modifiers are intended to give the user flexibility in creating a translucent or opalescent natural looking prosthetic. NobelRondo also includes mixing liquids and shade guides. The various porcelains and modifiers are used in a build-up process. After applying each layer, the restoration is fired following directions in the Instructions for Use. All of the component porcelains and modifiers can be used in combination without restriction. The dental technician will use the components as needed to create the desired prosthetic. However, typical use includes using a base liner followed by a build-up material and finally glazes and stains. Throughout this process, modifiers for translucent and opalescent effects can be added. The NobelRondo Dental Ceramic – Zirconia is sold in kit form. The various porcelains and modifiers are packaged in polyethylene bottles with screw caps. Replacement bottles for each porcelain or modifier are available individually.
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