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510(k) Data Aggregation
K Number
K211396Device Name
Neoss Individual Prosthetics
Manufacturer
Neoss Ltd
Date Cleared
2022-05-17
(377 days)
Product Code
NHA
Regulation Number
872.3630Why did this record match?
Applicant Name (Manufacturer) :
Neoss Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Neoss Individual Prosthetics are designed to be connected to Neoss Implants and intended for use as an aid in prosthetic rehabilitation. All digitally designed CAD/CAM customizations for the Neoss Individual Abutments are only intended to be sent to and manufactured by an FDA registered and Neoss approved milling facility. Digital designs for Individual Bars/Bridges are sent to Neoss.
Device Description
Neoss Individual Prosthetics are endosseous dental implant abutments used to support single tooth restorations (Abutment) or multi-unit prosthetic restorations (Abutment, Bridge or Bar) on Neoss Implants on implant level or abutment level. Neoss Individual Prosthetics are generally produced with straight screw channels (SSC) to be used with Neo Abutment screws and Neo Screwdrivers. Neoss Individual Prosthetics also features the option to customize the angulation of the screw access channel. Compatible Neoss Implant System includes two implant/prosthetic interfaces, i.e. platforms, SP and NP. Neoss Implant System also includes one abutment/prosthetic interface. This platform is called Access with a platform diameter of 4.0 mm.
Neoss Individual Abutments are patient specific and are manufactured from Abutment Blanks. Blanks are hollow metal cylinders available in either Titanium (grade 4 ASTM F67 or Ti-6A1-4V alloy ASTM F136). The blank has a precision milled prefabricated Neoss® implant connection (NeoLoc®) for the SP and NP platforms. The top part of the blanks can be milled to a patient-specific shape. The design of the patient-specific shape of the abutment is performed by a licensed clinician or dental technician and then verified for compliance with the abutment design limits by Neoss or a Neoss approved milling facility. Following the verification of the design the CAD/CAM processing and production of the individual prosthetics is conducted by Neoss or a Neoss approved milling facility. The finished abutment is attached to a Neoss Implant with a screw and a screwdriver at a set torque that depends on the platform.
Neoss Individual Bridges are patient specific and are manufactured from bulk material in Titanium (Ti-6Al-4V alloy ASTM F136).The posts that attach to Neoss Implants, optionally with intermediate Neoss Access Abutments, have a pre-defined interface, SP, NP or Access, to assure compatibility. The design of the patient-specific shape of the bridges is performed by a licensed clinician or dental technician and then verified for compliance with the bridge design limits by Neoss. Following the approval of the design, CAD/CAM processing and production of the individual prosthetics is conducted by Neoss. The implant interface is manufactured to Neoss specification to facilitate compatibility with Neoss platforms SP, NP or Access. The finished bridge is attached to a Neoss Implant or Neoss Access abutment with a screw and a screwdriver at a set torque that depends on the platform.
Neoss Individual Bars are patient specific and are manufactured from bulk material in Titanium (Ti-6Al-4V alloy ASTM F136). The posts that attach to Neoss Implants, optionally with intermediate Neoss Access Abutments, have a pre-defined interface to assure compatibility. The bars are designed for use with full or partial removable dentures and can be made with pre-defined design features making them compatible with commercially available precision attachments. The design of the patient-specific shape of the bars is performed by a licensed clinician or dental technician and then verified for compliance with the bar design limits by Neoss. Following the approval of the design, CAD/CAM processing and production of the individual prosthetics is conducted by Neoss. The implant interface is manufactured to Neoss specification to facilitate compatibility with Neoss platforms SP, NP or Access. The finished bar is attached to a Neoss Implant or Neoss Access abutment with a screw and a screwdriver at a set torque that depends on the platform.
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K Number
K150669Device Name
Neoss TiBase, Neoss CoCr Abutments (Mono and Multi)
Manufacturer
Neoss Ltd
Date Cleared
2015-10-08
(206 days)
Product Code
NHA
Regulation Number
872.3630Why did this record match?
Applicant Name (Manufacturer) :
Neoss Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Neoss TiBase:
Neoss Abutments are designed to be connected to the Neoss Implants and intended for use as an aid in prosthetic rehabilitation.
The Neoss TiBase is compatible with the Sirona Dental System inCoris ZI Meso L. All digitally designed copings and/or crowns for use with the Neoss TiBase Abutments are to be designed and milled using the Sirona Dental CAD/CAM System.
Neoss CoCr Abutments:
Neoss abutments are designed to be connected to the Neoss Implants and intended for use as an aid in prosthetic rehabilitation.
Device Description
Neoss TiBase and CoCr Abutments are endosseous dental implant abutments used to support single tooth or multi-unit prosthetic restorations. All subject abutments have a platform interface that is compatible with Neoss implant diameters Ø3.5-5.5 mm. All Neoss implant sizes have a 4.1 mm implant platform regardless of endosseous implant diameter. Neoss TiBase abutments are provided in two prosthetic platform sizes, N (narrow) and W (wide), to accommodate different emergence profiles. The Neoss TiBase Abutment are patient specific abutments intended for the coping/crown to be designed using the Sirona CAD/CAM System. The Neoss TiBase Abutment can be screw retained.
Neoss CoCr abutments are available in two designs (Mono and Multi), one prosthetic platform size and one height (15 mm). The indexed Mono abutment can be used for single tooth screw-retained or cement-retained restorations. The non-indexed Multi abutment is used for multi-unit screw-retained restorations.
Neoss Crystaloc screw in TiN/Au coated titanium is used with the Neoss TiBase and CoCr Abutments.
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K Number
K143327Device Name
Neoss Ti Reinforced Membrane
Manufacturer
Neoss Ltd
Date Cleared
2015-04-13
(144 days)
Product Code
NPK
Regulation Number
872.3930Why did this record match?
Applicant Name (Manufacturer) :
Neoss Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
An implantable temporary non-resorbable device (membrane) for use as a spacer creation barrier in the treatment of local defects in the oral cavity in conjunction with tissue regeneration or augmentation. Neoss membranes are intended to be submerged and clinically implanted more than 30 days with an expected duration of implantation up of 6 months.
Device Description
The Neoss Ti Reinforced Membrane a multi-layer non-resorbable dental membrane intended to be surgically placed beneath the muco-periosteum to aid in regenerative healing in 1) bone or 2) bone/periodontal ligament defects of the oral cavity. The Neoss Ti Reinforced Membrane is composed of two layers of PTFE membrane material enclosing a Titanium(Ti) mesh. The Neoss Ti Reinforced Membrane is a passive, non-load bearing material. The small pores of the PTFE membrane material, allows passage of fluid and vapor; as well as a controlled cellular ingrowth for stability and a barrier for soft tissue penetration. The Ti mesh is unalloyed surgical grade Titanium ISO 5832-2 Grade 2. The titanium mesh reinforcement is intended for space creating and shape-maintaining which minimizes movements and subsequent exposure while implanted. Neoss Ti Reinforced Membrane is provided pre-shaped in a variety of shapes and sizes detailed below. The device is supplied sterile and single use.
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K Number
K113376Device Name
NEOSS PROACTIVE TAPERED IMPLANT
Manufacturer
NEOSS LTD
Date Cleared
2012-09-05
(294 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 Tapered Implant is for single-stage or two-stage surgical procedure and cement or screw retained restorations. The Neoss Tapered 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 Tapered Implant is a threaded, internal abutment connection, root-form titanium dental implant. The Neoss Tapered Implant consists of a number of implants with a diameter of Ø3.5 to Ø5.5 mm and lengths between 7.0 – 17.0 mm; all sizes have the same internal abutment connection dimension independent of implant diameter. The internal connection is equipped with interlocking elements for an insertion tool and the non-rotational locking of the abutment. The Neoss ProActive Tapered Implant System is intended for surgical placement into the bone of upper /lower jaw arches as a permanent anchorage for prosthetic devices, which can restore chewing function and aesthetic appearance. Supplied sterile. The Neoss Implant System has specific design characteristics for mating Neoss components such as implants, abutments and prosthetic components. Combining components that are not configured or dimensioned for correct mating can lead to mechanical failure of components, damage to tissue, or unsatisfactory esthetic results. Abutment screws made in gold alloy, titanium or Ti with TiN/Au are available. Screw driver connection is compatible with screwdrivers supplied by Neoss. The abutment screws are supplied non-sterile.
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K Number
K090452Device Name
NEOSS IMPLANT SYSTEM 03.25
Manufacturer
NEOSS LTD
Date Cleared
2009-05-22
(88 days)
Product Code
DZE, NHA
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 Implant System Ø3,25 is for single-stage and two-stage surgical procedures and cement or screw retained restorations. The Neoss Implant System Ø3,25 are intended for immediate loading 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. The Neoss Implant Ø3,25 abutments are designed to be connected to the Neoss implants and intended for use as an aid in prosthetic rehabilitation.
Device Description
The Neoss Implant System Ø3,25 assortment consists of a number of implants with a diameter of Ø3,25 mm and lengths between 9,0 - 17.0 mm having the same internal abutment designs as previously cleared per K083561 & K043195 & K071838, but a smaller diameter and includes a selection of abutments. Identical to K043195 & K083561, the Neoss Implant System Ø3,25 remains a threaded, internal abutment connection, root-form titanium dental implant. The internal connection being equipped with interlocking elements for an insertion tool and the non-rotational locking of the abutment. Smaller associated bone cutting instruments are also available. The Neoss Implant System Ø3,25 available surface treatment will be identical to either the Neoss Bimodal or Neoss ProActive Implant. Supplied sterile.
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K Number
K071838Device Name
NEOSS VARIOUS TITANIUM ABUTMENTS
Manufacturer
NEOSS LTD
Date Cleared
2007-10-19
(106 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 various Titanium Abutments are designed to be connected to the Neoss implants and intended for use as an aid in prosthetic rehabilitation.
Device Description
The Neoss Titanium Prepable Abutment 15°and 20° is designed to be modified and secured directly to the implant using an abutment screw and supplied non-sterile. The Neoss Express Abutment requires no modification and allows for abutment level impression taking. The Neoss Locator Abutment system, made by commercially pure titanium, designed to secured directly to the implant using an abutment screw and supplied non-sterile.
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K Number
K043195Device Name
NEO IMPLANT SYSTEM
Manufacturer
NEOSS LTD
Date Cleared
2005-03-07
(109 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 Neo Implants - Neo Implant System are for single-stage and two-stage surgical procedures and cement or screw retained restorations. The Neo Implants - Neo Implant System are 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
Implant fixture: miplant is a threaded, internal abutment connection, root-form titanium dental implant. The Neo implant assortment consists of a number of implants with a diameter of mynant. The Neo miplangths between 7.0 -- 19.0 mm having the same internal abutment dimension independent of implant diameter. The internal connection being equiped with interlocking elements for an insertion tool and the non-rotational locking of the abutitient. Supplied sterile.
Temporary part related to the fixture - Cover screw; Made in titanium for implantation. Supplied sterile.
Temporary part related to the fixture - Healing abutment; Made in titanium or PFEK for implantation. Supplied sterile.
Abutments: The Neo Abutment system is a set of modifiable gold alloy or commercially pure titanium abutments (Neolink), which are secured directly to the implant using an abutment screw. For easy wax-up a set of pre-shaped plastic copings can be used to fit to the abutment. Supplied non-sterile.
Prepable Ti abutments: Prepable titanium abutments of straight or angle (20 degrees or less) design made to be adjusted by clinician or dental technician. Crown or bridge cemented on prepped abutment. Supplied non-sterile.
Bar abutment; straight titanium or gold abutment cylinder to which a bar can be bonded (i.e welded or soldered) or cast on to. Supplied non-sterile.
Ball abutment; conventional design (ball head diameter 2,25 mm) used with standard attachments. Supplied non-sterile.
Abutment screw made in gold alloy or titanium. Screw driver connection compatible with screwdrivers supplied by Neoss. Supplied non-sterile.
Round bur; The round bur with diameter Ø1,8-2 with is ISO 1797-1 hand piece connection and shaft.
Twist drills: Two flute twist drill with ISO 1797-1 hand piece connection and shaft. Depth marking corresponding to the implant lengths in the Neoss implant system, hence 7, 9, 11, 13, 15 and 17. Diameter from Ø2.2 to Ø5,1 in appropriate steps to match the Neoss implants.
Screwtap: Screwtap for the different implant diameters existing in the Neo Implant system (Ø3,5 to Ø5,5) with ISO 1797-1 hand piece connection and shaft.
Countersink: Countersink, (05,5) with ISO 1797-1 hand piece connection and shaft. The tool has a centring tap in relation to the prepared hole.
Material of bone cutting instruments is medical grade stainless steel currently being used for similar components.
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