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Paltop Short Implants (Internal Hex and Conical Connections) are in surgical and restorative applications for placement in the bone of the upper or lower jaw as an artificial root structure for single tooth replacement or for fixed bridgework to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. Paltop Short Implants are indicated to be used only with straight abutments and are for delayed loading only.

The purpose of this submission is for the marketing clearance for the Paltop Short Implants which comprises endosseous root-form dental implants, cover screw, and compatible abutments.

The Subject device abutments are compatible with prior cleared implant bodies, and abutments from prior clearances are compatible with new Subject device implant bodies. Subject device abutments are also compatible with previously cleared implant bodies in K112795. Subject device are compatible with straight abutments previously cleared in K112795, K131451, K220200, and K221381.

Endosseous dental implants are surgically implanted into a patient's mouth to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. Endosseous dental implant abutments are secured to dental implants with a retaining screw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function.

The Paltop Short Implant System includes endosseous screw type dental implant bodies, which can be used in twostage surgeries with associated compatible abutments. The Subject device abutments provide a range of cementretained and screw-retained prosthetic solutions for dental implant restoration. Paltop Short Implant System includes six compatible implant abutment designs: Healing Caps, Straight, Temporary, Snap-On Abutment System (SAS) Abutment, and Straight Ball Abutment.

The implant bodies, titanium abutments and cover screw are fabricated from a Titanium 4 Vanadium ELI titanium alloy (Grade 23) which conforms to ASTM F136, Standard Specification for Wrought Titanium-6Aluminum-4Vanadium EU (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). The Subject device implant bodies are surface treated with SLA (Sand-blasted, Large Grit, Acid Etched). The Snap On Abutment System(SAS) Abutments are supplied sterile with a PEEK cap.

All implants and prosthetic components are one-time use device components are provided sterile and sterilized by gamma irradiation except for the replacement cover screws which are provided nonsterile. Devices provided as non-sterile are sterilized by steam.

I am sorry, but the provided text does not contain the specific details about the acceptance criteria or a study proving the device meets those criteria. The document is an FDA 510(k) summary for Paltop Short Implants, which focuses on demonstrating substantial equivalence to predicate devices rather than presenting detailed acceptance criteria and study results for device performance in the way you've requested.

The text does mention "Comparative testing in the form of Pull-Out, surface area and BIC testing was performed to ensure that the performance of the subject device is appropriate for its intended use," but it does not provide the acceptance criteria for these tests, nor does it present the reported device performance values from these tests. It also states that "static and dynamic testing were not required" because the device is not significantly different from predicate devices.

Therefore, I cannot fulfill your request for the detailed table and study information as the necessary data is not present in the provided document.

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