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The ZERAMEX® XT Dental Implant System is intended to be surgically placed in the bone of the upper and lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore aesthetics and chewing function. The ZERAMEX® XT Dental Implant System can be used for single or multiple unit restorations. The ZERAMEX® XT Dental Implants are indicated for delayed loading. The ZERAMEX® dental implants are specially indicated for patients with metal allergies/intolerances and chronic illnesses due to metal allergies/ intolerances. The NobelPearl Dental Implant System is intended to be surgically placed in the bone of the upper and lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore aesthetics and chewing function. The NobelPearl Dental Implant System can be used for single or multiple unit restorations. NobelPearl Dental Implant System are intended for delayed loading. NobelPearl Dental Implant System are specially indicated for patients with metal allergies/intolerances and chronic illness due to metal allergies/intolerances.

The Zeramex® XT Dental Implant System is an endosseous dental implant/abutment system including various sizes of endosseous two piece dental implants, abutments, and accessories. The Zeramex® XT implants may be restored with screw retained Zeramex® XT abutments. The Zeramex® XT implants are placed using the Zeramex® XT surgical tools. The NobelPearl Dental Implant System is an endosseous dental implant/abutment system including various sizes of endosseous two piece dental implants, abutments, and accessories. The NobelPearl Dental Implant System may be restored with screw retained NobelPearl abutments. The NobelPearl Dental Implant System are placed using the NobelPearl surgical tools. The implants, abutments, and surgical tools for the Zeramex® XT and NobelPearl Dental Implant Systems are exactly the same; two trade names are being used for marketing purposes. The implants, produced from aluminum toughened zirconia (conforming to ISO 6474-1:2010 Implants for Surgery - Ceramic Materials and ISO 6872:2015 Dentistry - Ceramic Materials), are provided sterile in two (2) diameters (0 4.2 mm (RB), and 5.5 mm (WB)) and three (3) lengths (8 mm, 10 mm, and 12 mm). The Ø 4.2 mm implant is also provided in 14 mm. The implants are designed with a "bolt-in tube" internal connection which provide anti-rotational features. Straight and angular (15°) screw retained abutments, provided non-sterile in two sizes (RB; Ø 5.0 mm and SB, Ø 6.0 mm), are compatible for use with the system implants. The straight and angular abutments are made from the same zirconium materials as the system implants. The screw retained abutments fit within four (4) retention elements and are affixed to the implant with a carbon fiber reinforced PEEK-Optima™ Ultra VICARBO® screw (straight) which fits the internal thread of the implant and provides a secure, screw retained ceramic on ceramic connection. Healing caps and gingivaformers are also provided in the system. These components, provided in two sizes, are manufactured from PEEK and are connected to the implant using a screw. Provisional restoration components may be used to support temporary crowns after the healing period. The provisional restorations and the provisional restoration screws are made of carbon fiber reinforced PEEK.

The Zeramex® P6 Dental Implant System is intended to be surgically placed in the bone of the upper and lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore aesthetics and chewing function. The Zeramex® P6 Dental Implant System can be used for single or multiple unit restorations. The Zeramex® P6 implants are intended for delayed loading. The Zeramex® P6 implants are specially indicated for patients with metal allergies/ intolerances and chronic illness due to metal allergies/intolerances. The Zeramex® P6 (Ø3.3mm SN) implant may only be used in the anterior teeth in the lower jaw and lateral incisor in the upper jaw.

The Zeramex® P6 Dental Implant System is an endosseous dental implant/abutment system including various sizes of endosseous two piece dental implants, abutments, and accessories. The Zeramex® P6 implants may be restored with cement retained abutments or screw retained abutments, depending on the dentist's preference. The Zeramex® P6 implants are placed using the Zeramex® P6 surgical tools. The implants, produced from aluminum toughened zirconia, are provided in three diameters (Ø 3.3 mm, 4.1 mm, and 4.8 mm),three lengths (8 mm, 10 mm, and 12 mm). The implants are designed with an internal cylindrical connection. Anti-rotational features include internal triangular designs and external hexagonal connections; the feature used depends on the restoration method selected. Straight and angular (15°) cement retained and screw retained abutments, provided in small neck (SN; 4.0mm) and regular neck (RN, 4.8mm) sizes, are compatible for use with the Zeramex® P6 implants. The straight and angular abutments are made from the same zirconium materials as the Zeramex® P6 implants. The cement retained Zeramex® Zeralock™ straight and angular abutments have a cylindrical connector which fits into the internal cylindrical connection of the implant and a hexagonal design which fits into the implant's internal triangular design and locks the abutment into place. This design mitigates rotation in six possible positions. The screw retained Zeramex® P6 abutments fit on the implant's external hexagonal connection such that rotation is mitigated in six possible positions. The Zeramex® P6 screw retained abutments are affixed to the implant with a carbon fiber reinforced PEEK-Optima™ Ultra (Endolign) screw which fits the internal thread of the implant and provides a secure, screw retained ceramic on ceramic connection. Locator abutments facilitate removable full restoration of the upper or lower jaw. Three sizes (heights 2/3/5 mm) for each platform (SN 4.0mm and RN 4.8mm) are provided for the Zeramex® P6 Dental Implant System and provide the Zeralock™ connection. The Zeramex® P6 Locators are made from ATZ. The Zeramex® Zeralock™ cement retained abutments are bonded to the implants using dental cements which have been tested and validated for use with the Zeramex® systems: Panavia" (K032455) and 3M ESPE RelyX (K111185). The screw retained abutments are attached to the implants using carbon-fiber reinforced (CFR) VICARBO screws (made of PEEK-Optima™ Ultra (Endolign)), which are provided as straight and angular screws in SN and RN sizes. Healing caps and gingivaformers are also provided in the system. These components, provided in SN and RN sizes, are manufactured from PEEK and are connected to the implant using a screw. The Zeramex® P6 Gingivaformers are provided in two (2) lengths (3 mm and 4 mm). Provisional restoration components may be used to support temporary crowns after the healing period. The Zeramex® P6 Provisional Restoration SN and RN are made of PEEK. The Zeramex® P6 Provisional Restoration Screw is made of carbon fiber reinforced PEEK. A closure screw (Ø3.5 mm) may be used in lieu of the healing cap to allow the gingiva to cover the platform during the healing period. This component is manufactured from PEEK.

The Zeramex® P6 Dental Implant System is intended to be surgically placed in the bone of the upper and lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore aesthetics and chewing function. The Zeramex® P6 Dental Implant System can be used for single or multiple unit restorations. The Zeramex® P6 implants are intended for delayed loading. The Zeramex® P6 implants are specially indicated for patients with metal allergies/ intolerances and chronic illness due to metal allergies/intolerances. The Zeramex® P6 (Ø3.3mm SN) implant may only be used in the anterior teeth in the lower jaw and lateral teeth in the upper jaw.

The Zeramex® P6 Dental Implant System is an endosseous dental implant/abutment system including various sizes of endosseous two piece dental implants, abutments, and accessories. The Zeramex® P6 implants may be restored with cement retained abutments or screw retained abutments, depending on the dentist's preference. The Zeramex® P6 implants are placed using the Zeramex® P6 surgical tools. The implants, produced from aluminum toughened zirconia, are provided in three diameters (Ø 3.3 mm. 4.1 mm. and 4.8 mm),three lengths (8 mm, 10 mm, and 12 mm). The implants are designed with an internal cylindrical connection. Anti-rotational features include internal triangular designs and external hexagonal connections; the feature used depends on the restoration method selected. Straight and angular (15°) cement retained and screw retained abutments, provided in small neck (SN: 4.0mm) and regular neck (RN. 4.8mm) sizes, are compatible for use with the Zeramex® P6 implants. The straight and angular abutments are made from the same zirconium materials as the Zeramex® P6 implants. The cement retained Zeramex® Zeralock™ straight and angular abutments have a cylindrical connector which fits into the internal cylindrical connection of the implant and a hexagonal design which fits into the implant's internal triangular design and locks the abutment into place. This design mitigates rotation in six possible positions. The screw retained Zeramex® P6 abutments fit on the implant's external hexagonal connection such that rotation is mitigated in six possible positions. The Zeramex® P6 screw retained abutments are affixed to the implant with a carbon fiber reinforced PEEK-Optima™ Ultra (Endolign) screw which fits the internal thread of the implant and provides a secure, screw retained ceramic on ceramic connection. Locator abutments facilitate removable full restoration of the upper or lower jaw. Three sizes (heights 2/3/5 mm) for each platform (SN 4.0mm and RN 4.8mm) are provided for the Zeramex® P6 Dental Implant System and provide the Zeralock™ connection. The Zeramex® P6 Locators are made from ATZ. The Zeramex® Zeralock™ cement retained abutments are bonded to the implants using dental cements which have been tested and validated for use with the Zeramex® systems: Panavia" (K032455) and 3M ESPE RelyX (K111185). The screw retained abutments are attached to the implants using carbon-fiber reinforced (CFR) PEEK-Optima™ Ultra (Endolign) screws (provided as straight and angular screws in SN and RN sizes). Healing caps and gingiva formers are also provided in the system. These components, provided in SN and RN sizes, are manufactured from PEEK and are connected to the implant using a screw. The Zeramex® P6 Gingiva formers are provided in two (2) lengths (3 mm and 4 mm). Provisional restoration components may be used to support temporary crowns after the healing period. The Zeramex® P6 Provisional Restoration SN and RN are made of PEEK. The Zeramex® P6 Provisional Restoration Screw is made of carbon fiber reinforced PEEK.

The Zeramex® T Dental Implant System is intended to be surgically placed in the bone of the upper and lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore aesthetics and chewing function. The Zeramex® T Dental Implant System can be used for single or multiple unit restorations. Zeramex® T implants are intended for delayed loading. The Zeramex® T dental implants are specially indicated for patients with metal allergies and chronic illnesses due to metal allergies. The Zeramex® T (Ø 3.5 mm) implant may only be used in the anterior teeth in the lower jaw and lateral teeth in the upper jaw.

The Zeramex® T System is an endosseous dental implant/abutment system. The Zeramex® T implants are placed using the Zeramex® T surgical tools. The implants are provided in three diameters (Ø 3.5 mm, 4.2 mm, and 5.5 mm) and three lengths (8 mm, 10 mm, and 12 mm). The Ø 4.2 mm implant is also offered in a 14 mm length. Dentalpoint AG offers several compatible abutments and other accessories including straight and angular (15°) abutments in small, regular/wide, and wide sizes, healing caps, and gingiva formers. The abutments are bonded to the implants using dental cements which have been tested and validated for use with the Zeramex system: Panavia (K032455) and 3M ESPE RelyX (K111185). Class I, 510(k) exempt accessories are provided in the Zeramex® T tray and include drill bits, screwdrivers, countertorque devices, placement and removal tools, laboratory pieces used for fabrication or dental prosthetics, and trial abutments. The surgical tools are intended to be reprocessed (cleaned, disinfected, and sterilized) after each procedure.