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The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage surgical procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with physiological occlusal loading. Multiple teeth applications can be rigidly splinted. The CR Abutment is an abutment placed over Neodent Zirconia Implants in order to provide support for prosthetic restorations, such as copings or crowns. It may be used for single-unit restorations that are cement-retained in esthetical areas over implants installed in maxilla or mandible.

- Intended for single use; - Provided sterile via Ethylene Oxide; - . All devices of Zirconia Implant System are manufactured of Y-TZP (Yttrium-stabilized zirconium dioxide); - . The CR Abutment for Zirconia system is supplied along with a titanium alloy screw (ASTM F136); - ZiLock prosthetic interface with internal indexer; - Apically tapered implant with trapezoidal thread profile; - Implant provided with sand-blasted, acid etched surface finish; - . The subject Implants are compatible with the Zirconia Bases (already cleared per market per K201491) and CR Abutments (subject of this submission); - . The subject CR Abutments are compatible with the Zirconia Implants 4.3 mm (already cleared per market per K201491) and Zirconia Implants 3.75 mm (subject of this submission).

Neodent prosthetic abutments are indicated to be used on Neodent implants to provide support for prosthetic structures for up to 6 months. They can be used in single- or two-stage procedures and they are intended to be placed out of occlusion.

The subject device is a temporary abutment composed of PEEK with a titanium alloy fixation screw. The subject device is compatible with Neodent zirconia implant bodies with Zilock connection platform (K201491). - Intended for single use; - Provided sterile via Ethylene Oxide; - The subject devices are manufactured of PEEK (high performance polymer – specific for dental use) and are provided along with a screw manufactured of titanium alloy according to ASTM F136 standard; - . ZiLock prosthetic interface with internal indexer; - . Cylindrical format with a passing hole to fixate the screw.

- HE (External Hex) implants, stock abutments and stock copings (originally cleared per K101207) - Titamax CM (Cone Morse) implants, stock abutments and stock copings (originally cleared per K101945 ● and extended per K123022, K133696 and K150199) - Titamax CM (Cone Morse) EX implants, stock abutments and stock copings (originally cleared per K101945 and extended per K123022, K133696 and K150199) - Alvim CM (Cone Morse) implants, stock abutments and stock copings (originally cleared per K101945 and ● extended per K123022, K133696 and K150199) - CM (Cone Morse) Drive implants, stock abutments and stock copings (originally cleared per K123022 and extended per K133696, K150182 and K150199) - GM (Grand Morse) Titamax implants, stock abutments and stock copings (originally cleared per K163194) - GM (Grand Morse) Drive implants, stock abutments and stock copings (originally cleared per K163194) ● - . GM (Grand Morse) Helix implants, stock abutments and stock copings (originally cleared per K163194) The implants, abutments and copings of the Neodent Implant System are intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Multiple tooth applications may be rigidly splinted. - Titamax WS implants, abutments and copings (originally cleared per K123022) The implants, abutments and copings of the Neodent Implant System are intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices such as artificial teeth to restore chewing function. The Neodent Implant System may be used for single or multiple unit restorations. Multiple tooth applications may be rigidly splinted. The Titamax WS implants are indicated for a delayed loading protocol. - Facility implants, stock abutments and stock copings (originally cleared per K123022 and extended per K133696 and K150199) The implants, abutments and copings of the Neodent Implant System are intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices such as artificial teeth to restore chewing function. The Neodent Implant System may be used for single or multiple unit restorations. Multiple tooth applications may be rigidly splinted. The Facility implants of the Neodent Implant System are indicated for replacement of maxillary lateral incisors, mandibular incisors or retention of overdentures. - Zygomatic implants, stock abutments and stock copings (originally cleared per K141777) The Zygomatic implants, abutments and copings of the Neodent Implant System are intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Multiple tooth applications may be rigidly splinted. The Zygomatic implants of the Neodent Implant System are indicated for surgical installation in the zygoma region in cases of severe jaw resorption in order to restore patient esthetics and chewing function. Zygomatic implants are recommended for the posterior (pre-molar/ molar) region, one implant on each side, with at least two standard dental implants in the anterior region to support a fixed restoration. - CM (Cone Morse) Titanium Base Abutment component of two-piece patient-specific abutment (originally cleared per K150367 and extended per K153624) - o GM (Grand Morse) Exact Titanium Base Abutment component of two-piece patient-specific abutment (originally cleared per K163194) The implants, abutments and copings of the Neodent Implant System are intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Multiple tooth applications may be rigidly splinted. The Titanium Base Abutment is a titanium base placed onto Neodent dental implants to provide support for customized prosthetic restorations. The Titanium Base is used with a coping and crown, or crown alone, and is indicated for cement-retained single or multi-unit restorations, or screw-retained single restorations. All digitally designed copings and/or crowns for use with the Neodent Titanium Base Abutment are intended to be sent to Straumann for manufacture at a validated milling center. - CM (Cone Morse) Titanium Base for CEREC Abutment component of two-piece patient-specific abutment (originally cleared per K160964) The implants, abutments and copings of the Neodent Implant System are intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Multiple tooth applications may be rigidly splinted. The Titanium Base for CEREC Abutment is a titanium base placed onto Neodent dental implants to provide support for customized prosthetic restorations. They are used with a coping and crown, or crown alone, and is indicated for cement-retained single or multi-unit restorations, or screw-retained single restorations. All digitally designed copings and/or crowns for use with the Neodent Titanium Base for CEREC Abutment are to be designed using Sirona inLab software or Sirona CEREC Software and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit. - CM Preface Abutment component of patient-specific abutment (originally cleared per K150367) The implants, abutments and copings of the Neodent Implant System are intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Multiple tooth applications may be rigidly splinted. The Preface Abutment is a titanium abutment to be used in fabricating a full custom abutment placed onto Neodent dental implants to provide support for customized prosthetic restorations. The Preface Abutments is indicated for screw-retained single restorations or cement-retained single or multi-unit restorations. All digitally designed restorations for use with the Neodent Preface Abutment are intended to be sent to Straumann for manufacture at a validated milling center. - GM (Grand Morse) ProPEEK Abutments (originally cleared per K163194) ● - CM (Cone Morse) ProPEEK Abutments (originally cleared per K170080) The implants, abutments and copings of the Neodent Implant System are intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Multiple tooth applications may be rigidly splinted. The Pro PEEK Abutment is indicated to be used on Neodent implants to provide temporary support for prosthesis structure for up to 6 months. - Neodent Implant for Orthodontic Anchor (originally cleared per K102769) ● The Neodent Implant for Orthodontic Anchor is a surgical device in the form of a temporary screw used as an aid in orthodontic movement procedures. - . The Neodent Graft Screw (originally cleared per K103084) The Neodent Graft Screw is an implantable device used for fixation of bone blocks for the regeneration of bone in the oral cavity. The product is intended for temporary use only.

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The Pro PEEK Abutments are indicated to be used on Neodent implants to provide temporary support for prosthesis structure for up to 6 months. They can be used in one or two stage procedures and also immediate load when there is good primary stability.

CM Pro PEEK abutments are temporary intermediary prosthetic components to be installed onto CM Implants to support the provisional prosthesis up to 6 months. They are composed of a customizable cylindrical body with an internal channel for the screw access and of a base for anti-rotational implant connection. The customizable portion is manufactured in PEEK (high performance polymer – specific for dental use) and the implant-to-abutment interface is made of titanium alloy. They have a coupled screw for fixing them to the Implant. They present a hexagonal indexing at the apical end of the Morse taper connection to provide anti-rotational feature to the implant-to-abutment connection, and facilitates proper alignment of the prosthesis to the implant. They are available in diameters of 4.5 and 6.0 mm and in lengths of 0.8, 1.5, 2.5, 3.5, 4.5 and 5.5 mm. The customization of the PEEK chimney must be done into the mouth of patient or chairside. Chairside customization means that the device preparation must be done in a controlled environment in the operating room, in the context of the prosthetic placement, in a surgical site's aseptic environment using sterilized tools. The dentist can wear the PEEK chimney with the aid of suitable techniques, high speed handpiece and cooling, according to the patient interocclusal space, respecting the minimum of 5mm of height. No customization is allowed for the diameter/ wall thickness of the abutment, as well as no angulation. No CAD/CAM design and fabrication is allowed for the CM Pro PEEK Abutments. Only hand-milling may be used for abutment modification. The CM Pro PEEK abutments can be used before the installation of the final prosthesis to maintain, stabilize and shape the soft tissue (gum) during the healing phase.

Indications for Use for GM implants and conventional abutments: The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Indications for Use for GM Titanium Base abutments: Titanium Base Abutment is a titanium base placed onto Neodent dental implants to provide support for customized prosthetic restorations. It is used with a coping and crown, or crown alone, and is indicated for cement-retained single or multi-unit restorations, or screw-retained single restorations. All digitally designed copings and/or crowns for use with the Neodent Titanium Base Abutment System are intended to be sent to Straumann for manufacture at a validated milling center. Indications for Use for GM Pro Peek Abutments: The Pro PEEK Abutments are indicated to be used on Neodent implants to provide temporary support for prosthesis structure for up to 6 months. They can be used in one or two stage procedures and also immediate load when there is good primary stability.

The GM Line of the Neodent Implant System (GM Line) consists in an expansion of the Neodent Implant System previously cleared under K101945, K150182 and K153624, presenting a new design of Morse taper implant-to-abutment interface trade named GM line. The GM line comprises a range of endosseous dental implants as well as conventional and CAD/CAM abutments described as follows: The GM Line dental implants are threaded, self-tapping, root form with a Morse taper implantto-abutment interface with an internal hexagonal index exclusive to the GM line. They are made of titanium grade 4 conforming to ASTM F67. They are available in two types of surface treatment: NeoPoros: rough surface created using an abrasive particle jet concept with controlled grain oxides, followed by acid etching creating uniform cavities in the implant surface. Acqua: hydrophilic surface created from Neoporos rough surface that undergoes additional processing that renders hydrophilic surface. GM Titamax implants: cylindrical shape with double threads of pyramidal profile, rounded apex. GM Helix implants: conical shape, double threads with trapezoidal profile, a rounded apex. GM Drive implants: conical shape with double and progressive threads, cutting chambers in the counterclockwise direction, blade-shaped apical thread, rounded apex. The GM Line dental abutments are made of titanium alloy conforming to ASTM F136 and have a machined surface. The abutments are intended to be placed directly onto implants and are recommended according to the available interocclusal space, gingival height, and threedimensional position of the implant. They can be used in immediate or conventional rehabilitation procedures on the maxilla or mandible. GM Cover Screws: devices for temporary use during the implant healing phase. GM Healings: devices for temporary use for maintenance of the soft tissue during the osseointegration phase. GM Micro Abutments / GM Mini Conical Abutment / GM Exact Mini Conical Abutment: intermediary prosthetic components to be installed onto GM implants to support the final prosthesis. GM Exact Abutments: intermediary prosthetic components to be installed onto GM implants to support the final prosthesis. GM Exact Click Universal Abutments (straight and angled): intermediary prosthetic components to be installed onto GM implants to support the final prosthesis. GM Exact Titanium Base abutments: intermediary prosthetic components to be installed onto GM implants to support the final prosthesis; the Titanium Base two-piece abutments used as a base when fabricating a CAD/CAM customized restoration. GM Pro PEEK Abutment: temporary intermediary prosthetic components to be installed onto the Implants to support the provisional prosthesis up to 6 months. Protection Cylinders: prosthetic components with a tapered shape intended to be placed on abutments to protect them during the fabrication of the prosthesis and/or healing of the peri-implant tissues. Coping Screws: prosthetic devices intended for coping fixation on the corresponding GM (screw-retained) abutment.

The Titanium Base for CEREC is a titanium component that is placed over Neodent Implants to provide support for custom prosthetic restorations, such as copings or crowns. It is indicated for single-tooth screw-retained restorations. All digitally designed copings and/or crowns for use with the Neodent Titanium Base for CEREC are to be designed using Sirona inLab software or Sirona CEREC Software and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit.

The Titanium Base for CEREC consists of a two-piece abutment, where the titanium base is a pre-manufactured abutment that will be used to support a CAD/CAM designed superstructure (the second part of the two-piece abutment) that composes the final abutment. The Titanium Base for CEREC abutments are made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surqical Implant Applications and are provided in a 4.65 mm prosthetic platform diameter and seven gingival heights (0.8, 1.5, 2.5, 3.5, 4.5, 5.5 and 6.5 mm), all having a 4.7 mm prosthetic height. They also feature: - cylindrical shape - hexagonal indexing at the apical end of the Morse taper connection - indexing guide in the cementable portion for coping fitting The CAD/CAM customized superstructure that composes the final abutment must be designed and milled through the Sirona Dental CAD/CAM System, according to the prosthetic planning and patient clinical situation. The Titanium Base for CEREC is provided sterile by Ethylene Oxide and steam sterilization is recommended after the cementation of the customized superstructure on the Titanium Base for CEREC. The Titanium Base for CEREC is compatible with the following devices: Dental implants All Neodent dental implants having Morse taper implant-to-abutment interface (CM line) cleared under K101945, K123022, K133592, K150182 and K150199. Raw material blanks - -InCoris Zi (ZrO2) by Sirona Dental Systems GmbH, L size blanks, cleared under K123664; - -IPS e.max CAD Abutments Solutions (LiSi₂) by Ivoclar Vivadent AG, L size blanks, cleared under K132209. Software Sirona Dental CAD/CAM System, by Sirona Dental Systems GmbH, cleared under K111421. Instruments - -Neodent screwdrivers (class I - exempt devices) - Sirona scanbodies (class I exempt devices)