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510(k) Data Aggregation
K Number
K081851Device Name
NEOSS ACCESS ABUTMENTS
Manufacturer
NEOSS, LTD.
Date Cleared
2009-03-02
(245 days)
Product Code
NHA, ABU
Regulation Number
872.3630Why did this record match?
Applicant Name (Manufacturer) :
NEOSS, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Neoss Access Abutments are designed to be connected to the Neoss implants and intended for use as an aid in prosthetic rehabilitation.
Neoss Access Abutments represent a two piece abutment system and are designed to be connected to the Neoss implants, to receive another abutment or framework and intended for use as an aid in multiple-unit prosthetic rehabilitation such as dental bridge restorations.
Device Description
The internal connection of the Neoss Access Abutment provides a solution with a minimum height of the complete prosthesis of 5 mm and allows an overall implant alignment of up to 60 degrees without restraining the fabrication of a multiple-unit screw-retained restoration.
The angulated 10°, 20° and 30° abutments are intended for multi-unit cases in order to improve the position of the screw access hole.
Restorations can be based on Neolinks being incorporated into gold or ceramic frameworks, or solid titanium and ceramics frameworks. The frameworks are then tightened with prosthetic screws onto the Neoss Access Abutments.
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K Number
K083561Device Name
NEOSS PROACTIVE IMPLANT
Manufacturer
NEOSS, LTD.
Date Cleared
2009-02-11
(71 days)
Product Code
DZE
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
NEOSS, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Neoss ProActive Implant is for single-stage and two-stage surgical procedures and cement or screw retained restorations. The Neoss ProActive Implant is intended for immediate placement and function on single tooth and /or multiple tooth applications recognizing sufficient bone stability and appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be splinted with a bar.
Device Description
The Neoss ProActive is an modified version of the Neoss Bimodal Implant (K043195), Identical to K043195, the ProActive Implant is a threaded, internal abutment connection, root-form titanium dental implant. The ProActive assortment consists of a number of implants with a diameter of Ø3,5 to Ø5,5 mm and lengths between 7,0 - 19.0 mm having the same internal abutment dimension independent of implant diameter. The internal connection being equipped with interlocking elements for an insertion tool and the non-rotational locking of the abutment. Supplied sterile.
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