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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.

This document is a 510(k) summary from the FDA for a dental implant system. As such, it does not contain the detailed information required to describe acceptance criteria and associated study results for a medical device's performance.

Specifically, the document states under "VII. Performance Data": "New performance data is not required in support of this submission. The sterilization validation, shelf-life studies, biocompatibility studies, mechanical testing, and clinical studies from K152385 are applicable to this submission." This indicates that the current submission (K163043) is relying on previously submitted data for its predicate device (K152385) and does not present new performance studies. The changes made in this 510(k) (addition of a closure screw, administrative updates, additional contraindications, and a minor word revision in the Indications for Use) were deemed not to require new performance data.

Therefore, I cannot provide the information requested in your prompt because the provided document does not contain new performance study data, acceptance criteria, sample sizes, expert qualifications, or adjudication methods for the Zeramex® P6 Dental Implant System related to this specific 510(k) submission (K163043). The document is a regulatory approval notice based on substantial equivalence, not a detailed report of a new performance study.

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