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510(k) Data Aggregation
K Number
K110171Device Name
NOBELPROCERA ZI ABUTMENT THOMMEN PLATFORMS
Manufacturer
NOBEL BIOCARE USA LLC
Date Cleared
2011-06-15
(146 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 Zi Abutments Thommen Platforms are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. They are compatible with the Thommen Medical SPI 3.5, 4.0, 4.5, 5.0, and 6.0 implants.
Device Description
Nobel Biocare's NobelProcera Zi Abutment Thommen Platforms is an endosseous dental implant abutment. The abutment attaches directly to Thommen dental implants and provides a platform for restoration.
Nobel Biocare's NobelProcera Zi Abutments are designed and made individually to fit the individual requirements for each patient. The NobelProcera Zi Abutments are made entirely of zirconium oxide.
The abutments fit the Thommen SPI implant systems platform 3.5, 4.0, 4.5, 5.0, 6.0.
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K Number
K073142Device Name
NOBELREPLACE HEXAGONAL IMPLANT
Manufacturer
NOBEL BIOCARE USA LLC
Date Cleared
2008-01-11
(65 days)
Product Code
DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
NOBEL BIOCARE USA LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Nobel Biocare's NobelReplace Hexagonal 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. The NobelReplace Hexagonal Implants are indicated for single or multiple unit restorations. The NobelReplace Hexagonal Implants can be used in splinted or non-splinted applications. The NobelReplace Hexagonal Implants may be placed immediately and put into immediate function provided that initial stability requirements detailed in the manual are satisfied.
Device Description
NobelReplace Hexagonal Implants are threaded, root-form dental implants intended for use in the upper and lower jaw arches to support prosthetic devices, such as an artificial tooth, in order to restore esthetics and chewing function to partially or fully edentulous patients.
The NobelReplace Hexagonal Implants are similar in design to the implants cleared under NobelReplace Tapered Conical Connection, K062566. The predicate internal square was changed to internal bexagonal connection.
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K Number
K062566Device Name
NOBELREPLACE TAPERED CONICAL CONNECTION
Manufacturer
NOBEL BIOCARE USA LLC
Date Cleared
2006-12-06
(97 days)
Product Code
DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
NOBEL BIOCARE USA LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Nobel Biocare's NobelReplace Tapered Conical Connection implants are endosseous dental 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. The NobelReplace Tapered Conical Connection implants are indicated for single or multiple unit restorations. The NobelReplace Tapered Conical Connection implants can be used in splinted or nonsplinted applications. The NobelReplace Tapered Conical Connection implant may be placed immediately and put into immediate function provided that initial stability requirements detailed in the manual are satisfied.
Device Description
Nobel Biocare's NobelReplace Tapered Conical Connection implants are threaded, root-form dental implants intended for use in the upper and lower jaw arches to support prosthetic devices, such as an artificial tooth, in order to restore esthetics and chewing function to partially or fully edentulous patients.
The NobelReplace Tapered Conical Connection implants are similar in design to the NobelReplace Tapered implants cleared under "Groovy Implants" (K050258). Like the NobelReplace Tapered implant, the NobelReplace Tapered Conical Connection implant is machined from commercially pure titanium, grade 4, have a tapered body contour, grooves on the collar, grooves on the threads of the body, and a TiUnite surface treatment. The difference between the two implants is that the NobelReplace Tapered Conical Connection implants have the same internal connection as the SFB implants, cleared under "SFB & CFB Implants"(K061003). The internal conical connection allows for the use of SFB abutments.
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K Number
K052885Device Name
ZYGOMA 17 ABUTMENT MULTI-UNIT RP 2MM, MODEL 29314; ZYGOMA 17 ABUTMENT MULTI-UNIT RP 3MM, MODEL 29315
Manufacturer
NOBEL BIOCARE USA LLC
Date Cleared
2005-12-23
(71 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 Nobel Biocare Zygoma Angled Abutment is intended to be used as a prosthetic component directly The Zygonia Angled Abdamont is intended for use as an aid in prosthetic rehabilitation.
The Nobel Biocare Zygoma Angled Abutment is intended to be used as a prostherity in The Nobel Blocare Zygoma Angled Koathent is intended for use as an aid in prosthetic rehabilitation.
The Nobel Biocare Zygoma Angled Abutment is intended to be used as a prosthetic The Nobol Elocal o Eygoniant and is intended for use as an aid in prosthetic rehabilitation.
Device Description
The Zygoma Angled Abutment is an artificial tooth abutment designed to fit and function on Nobel Biocare's Zygoma implant.
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K Number
K050641Device Name
ZYGOMA TIUNITE
Manufacturer
NOBEL BIOCARE USA LLC
Date Cleared
2005-04-07
(24 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
Nobel Biocare's Zygoma TiUnite® is a titanium, endosseous implant with components intended to be placed in the upper jaw in order to provide support for prosthetic devices such as artificial teeth in order to restore patient esthetics and chewing function.
Device Description
Nobel Biocare's Zygoma TiUnite® includes endosseous implants, a cover screw, healing abutments, and multi-unit abutments.
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