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Simply Iconic™ dental implants are two-piece implants for one-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and termediate abutment support for fixed bridgework. Implants can be indicated for immediate loading when stability has been achieved and with appropriate occlusal loading.

Legacy2, simplyLegacy2, Legacy3, simplyLegacy3, and Legacy4 dental implants are two-piece implants for one-stage or twostage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework. Implants can be indicated for immediate loading when good primary stability has been achieved and with appropriate occlusal loading. The Legacy 2, Legacy3, and Legacy4 fixture-mounts are intended for use with the corresponding dental implants (Legacy3, and Legacy4, respectively). The fixture-mounts can function as an abutment, fixture-mounts are intended for use with dental implants in the maxillary and/or mandbular arches to provide support for crowns or bridges for edentulous or partially edentulous patients.

Custom Titanium Abutments are customizable devices intended for use with dental implants in the maxillary and or mandibular arches to provide support for crowns or bridges for edentulous or partially edentulous patients.

The Legacy™ SMARTBase Abutment system is designed to be used in support of a dental implant(s) to provide support for prosthetic restorations in a partially edentulous patient. Legacy SMARTBase engaging abutments are intended for use in the mandible or maxilla in support of single unit restorations.

InterActive/SwishActive Implant System consists of two-piece implants for one-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or internediate SMARTBase support for fixed bridgework.

Implant Direct Custom Bars are patient specific devices indicated for attachment to dental implants in the treatment of partially or fully edentulous jaws for the purpose of restoring chewing function.

GPS® Angled Abutments are designed to be used in support of a dental implant(s) to provide support for prosthetic restorations in a partially or completely edentulous patient. These abutments are designed to only receive a fabricated multi-unit bridge or overdenture. Abutments are intended for use in the mandible or maxilla. Implants can be indicated for immediate loading when good primary stability has been achieved and with appropriate occlusal loading.

InterActive/SwishActive Implant System consists of two-piece implants for one-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multipleunit restorations and terminal or intermediate abutment support for fixed bridgework. Implants can be indicated for immediate loading when good primary stability has been achieved and with appropriate occlusal loading.

Legacy3 6mm Length consists of two-piece implants for one-stage or two-stage surgical procedures. There implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or internediate abutment support for fixed bridgework. Implants can be indicated for immediate loading when good primary stability has been achieved and with appropriate occlusal loading.

InterActive/SwishPlus2 Implant System consists of two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework: Implants can be indicated for immediate loading when good primary stability has been achieved and with appropriate occlusal loading.

Spectra-System Dental Implants 2008 are comprised of dental implant fixtures and prosthetic devices that compose a two-piece implant system. The implants are intended for use in the mandible and maxilla, in support of single unit or multiple unit cement or screw-receiving restorations and for the retention and support of overdentures. The implants are intended for immediate placement and function for the support of single-tooth restorations, recognizing bone stability and appropriate occlusal load requirements.

The SwissPlant Dental Implant system consists of two-piece implants for one or two-stage surgical procedures that are intended for use in partially or fully edentulous maxillae, in support of single or multiple-unit restorations including: cement retained, screw retained or overdenture restorations and in terminal or immediate abutment support for fixed bridgework. The SwissPlant dental implants are intended for immediate placement and function on single tooth and/or multiple tooth applications recognizing initial implant stability and appropriate occlusal loading, to restore normal masticatory function.

Spectra-System Abutments are designed to be used in support of a dental implant(s) to provide support for prosthetic restorations such as crowns, bridges, overdentures or custom prosthetic fabrications in a partially or completely edentulous patient. Spectra-System Abutments are intended for use in the mandble or maxilla. Prostheses can be screw or cement retained to the abutment.

The ReActive Dental Implant System are dental implant fixtures that are a part of a two-piece implant system. The ReActive implants are intended for use in the mandible and maxilla, in support of single or multiple-unit cement or screw receiving fixed restorations and for retention and support of overdentures. The implants are intended for immediate placement and function for support of single tooth and/or multiple tooth restorations, recognizing bone stability and appropriate occlusal load requirements.

ScrewIndirect Narrow Dental Implants for single-stage surgical procedures intended for use in partially or fully edentulous mandibles and maxillae, in support of complete or partial denture prostheses or as a terminal or intermediary attachment for fixed or removable bridgework via interface with copings. These implants are intended for for support of splinted multiple tooth restorations, provided initial implant stability and appropriate occlusal load requirements are met.

The RePlus Dental Implants with HA coating are dental implant fixtures that are a part of a two-piece implant system. The RePlus implants are intended for use in the mandible and maxilla, in support of single or multiple-unit cement or screw receiving fixed restorations and for retention and support of overdentures. The immediate loading for support of single tooth and/or multiple tooth restorations, provided initial implant stability and appropriate occlusal load requirements are met.

The ScrewPlus Dental Implant with HA coating is a dental implant fixture that is a part of a two-piece implant system that is to be used for single-stage or two-stage surgical procedures. The ScrewPlus implants are intended for use in the mandible and maxilla, in support of single or multiple-unit cement or screw receiving fixed restoration and support of overdentures. The implants are intended for immediate placement and function for multiple tooth and/or multiple tooth restorations, recognizing bone stability and appropriate occlusal load requirements.

The Legacy Dental Implant with HA coating is a dental implant fixture that is a part of a two-piece implant system. The Legacy implants are intended for use in the mandible and maxilla, in support of single or multiple-unit cement or screw receiving fixed restorations and for retention and support of overdentures. The implants are intended for immediate placement and function for support of single tooth and/or multiple tooth restorations, recognizing bone stability and appropriate occlusal load requirements.

The Spectra Dental Implant System consists of one-piece implants for single-stage or two- stage surgical procedures that are intended for use in partially or fully edentulous mandillae, in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework. They may be placed in immediate function if initial implant stability can be established.

The Legacy Abutment System is intended for use with dental implants in the maxillary and/or mandbular arches to provide support for crowns, bridges, or overdentures for edentulous or partially edentulous patients.

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The provided text is a compilation of Indications for Use statements for various dental implant systems and components, all under the umbrella of "Implant Direct Dental Implant Systems Portfolio - MR Conditional." Each section describes the intended use for a specific product or family of products, often referencing previous 510(k) clearances.

Crucially, this document does not contain any information about acceptance criteria or studies that prove the device meets these criteria. It is a regulatory filing for the Indications for Use for a medical device which has already been cleared by the FDA to be "substantially equivalent" to predicate devices.

Therefore, I cannot fulfill the request to describe acceptance criteria and the study that proves the device meets the acceptance criteria based solely on the provided text. The document is for describing what the device is for, not how its performance was tested or validated.

To provide the requested information, I would need a different type of document, such as a summary of safety and effectiveness, a clinical study report, or a validation plan for a specific performance characteristic.

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Simply Iconic™ dental implants are two-piece implants for one-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.

Implants can be indicated for immediate loading when good primary stability has been achieved and with appropriate occlusal loading.

• Narrow (3.2mmD) implants: Indicated for single-tooth replacement (mandibular central and lateral incisors; maxillary lateral incisors), multiple-tooth replacements or denture stabilization.

· Short (6mm) 3.7mmD implants: Indicated for single-tooth (mandibular and maxillary central and lateral incisors), multiple tooth replacements or denture stabilization.

The Simply Iconic™ implants are two-piece dental implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.

The top one-third (coronal part) of the Simply Iconic™ implant body is straight, with quadruple-lead micro-threads on the coronal aspect, and the lower two-thirds is tapered with dual-lead progressively deeper buttress threads. This design is intended for increased bone-to-implant contact (BIC). Three cutting flutes extend over the tapered portion of the implant body to make bone tapping unnecessary for implant insertion.

The dental implant body are available in several diameter sizes (ranging from 3.2mmD - 7.0mmD), platform diameters (3.0, 3.4mmD) and lengths (ranging from 6 - 16 mm).

The Simply Iconic™ dental implants utilize the same implant abutment interface as the Implant Direct InterActive implants and are compatible with corresponding 3.0 and 3.4 mm platform InterActive abutments.

The Simply Iconic™ dental implants are composed of titanium 6AI4V ELI metal, anodized titanium 6Al4V ELI colors (magenta or gold). Soluble Blast Media (SBM) surface treatments with Hydroxyapatite (HA) blast media. SBM implant surfaces have a micro texture created on defined areas of the implant. The Simply Iconic™ dental implants are packaged sterile supplied with a cover screw and a 5mm healing collar.

The provided text is a 510(k) Summary for a dental implant device. It primarily details the comparison of the new device (Simply Iconic™ Implants) to predicate devices to establish substantial equivalence. It does not describe an AI/ML powered device, nor does it include information about acceptance criteria or studies related to AI/ML performance.

Therefore, I cannot fulfill the request as the document does not contain the required information for an AI/ML powered device, such as acceptance criteria tables, sample sizes for test/training sets, expert ground truth details, adjudication methods, or MRMC studies.

The document focuses on non-clinical testing for substantial equivalence of a physical dental implant, covering aspects like biocompatibility, fatigue, surface area analysis, pullout testing, insertion torque, sterilization, and shelf life.

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JTK One-Piece Integrated Implant System:

The JTK one-piece integrated dental implant system is intended to replace single or multiple teeth in the fully or partially edentulous mandibular or maxillary alveolar process. The implants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

JTK Two-Piece Implant System:

The JTK two-piece dental implant system is comprised of dental implant fixtures and prosthetic devices a two-piece implant system. The implants are intended for use in the mandla, in support of single unit or multiple unit cement or screw-receiving restorations and support of overdentures. The implants are intended for immediate placement and function for the support of single tooth restorations, recognizing bone stability and appropriate occlusal load requirements.

The JTK Dental Implant System is offered in two different models consist of a one-piece integrated implant system where the implant and abutment are machined from the same piece of titanium, and a traditional two-piece implant system that consists of an implant and abutment that are made from different pieces titanium and held together by way of a supplied titanium healing cap is also supplied with the two-piece implants and abutments are supplied individually packaged and sterile to the end user via gamma radiation. The healing cap is packaged with the implant and the attachment screw is packaged with the abutment. All implant System are made by traditional CNC manufacturing methods. For both models of the implant body, the threaded portion receives a surface modification using sandblasting and acid etching (SLA).

For the one-piece implant system, the implants are offered in two thread diameters (3.0 and 3.3 mm) and in three thread lengths (10, 13 and 15 mm). The integral abutment portion of the implant is contoured and machined, is without a surface modification, and is offered in two platform heights (4 and 6 mm).

For the two-piece implant system, the implants are offered in five thread diameters (3.8, 4.0, 4.5, 5.0 and 5.5 mm) and in four thread lengths (8, 10, 13 and 15 mm). The neck of the implant is conical in shape, 2.5 mm in height and has been machined and is without a surface modification. The two-piece implant bodies are considered a tissue level implant. The abutments that are used with the two-piece system are offered in two different models (straight and angled (15° and 25°). The straight abutments are offered in a diameter of 4.4 mm and in lengths of 4.2, 5.2, 6.2 and 8.2 mm. The 15° angled abutments are offered in a diameter of 4.4 mm and in lengths of 6.0 and 8.0 mm, while the 25° the angled abutments are offered in a diameter of 4.4 mm and in lengths of 6.0 and 10.5 mm.

The titanium used to manufacture the one-piece implants conform with ASTM F67, Standard Specification for Unalloyed Titanium, for Surgical Implant Applications while the titanium used to manufacture the abutments conform with ASTM F136, Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications.

The provided text is an FDA 510(k) Premarket Notification summary for the JTK Dental Implant System. It focuses on demonstrating substantial equivalence to predicate devices through comparisons of device characteristics and non-clinical performance data.

Crucially, this document describes a dental implant system, a physical medical device, not a software or AI/ML-based device. Therefore, the concepts of acceptance criteria for algorithm performance (like sensitivity, specificity, AUC), ground truth experts, adjudication methods, MRMC studies, or training/test sets in the context of an AI/ML algorithm are not applicable to this submission.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this document refer to the non-clinical performance testing required for medical devices to demonstrate safety and effectiveness and substantial equivalence to existing predicate devices.

Here's an interpretation based on the provided text, aligning with the type of device being discussed:

1. A table of acceptance criteria and the reported device performance:

The "acceptance criteria" here are generally international standards and FDA guidance documents that the device must conform to for safety and performance. The "reported device performance" indicates whether the device passed these tests.

2. Sample size used for the test set and the data provenance:

For this type of physical device, "sample size" refers to the number of physical units tested. The document does not specify exact numbers for each test (e.g., how many implants were tested for fatigue). The provenance is "Jiangyin Jintech Biotech Co., Ltd." in "Jiangyin City, Jiangsu Province, China," as they conducted the performance testing. These are non-clinical (laboratory) studies.

• Sample Size: Not explicitly stated for each test (e.g., number of implants for fatigue testing), but implied to be sufficient to meet the requirements of the standards.
• Data Provenance: Non-clinical (laboratory) testing conducted by Jiangyin Jintech Biotech Co., Ltd. in China.
• Retrospective or Prospective: These are laboratory tests specifically conducted for the submission, so they are prospective in nature to generate data to support the 510(k).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This concept is not applicable here. Ground truth is typically established for diagnostic or AI/ML performance. For a dental implant, "ground truth" relates to its physical and biological performance as measured by objective tests (e.g., fatigue strength, biocompatibility, sterilization efficacy) against established international standards. The "experts" are the engineers, scientists, and technicians who design, conduct, and analyze these standardized tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This concept is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation (e.g., radiologists interpreting images) to resolve disagreement. For physical device performance testing, the results are typically quantitative measurements against objective criteria, not subjective interpretations requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This concept is not applicable. An MRMC study is relevant for AI/ML-assisted diagnostic devices. This submission concerns a physical dental implant. There are no "human readers" or "AI assistance" in the context of this device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This concept is not applicable as this is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for this medical device is the adherence to established international consensus standards (e.g., ISO, ASTM) and FDA guidance for the physical, chemical, and biological properties of dental implants. For instance, the "ground truth" for fatigue is whether the implant can withstand 5x10^6 cycles without failure as per ISO 14801. The "ground truth" for biocompatibility is whether it passes cytotoxicity and pyrogen tests per ISO 10993. These are objective, quantifiable standards, not subjective interpretations.

8. The sample size for the training set:

This concept is not applicable. There is no "training set" for a physical dental implant system in the AI/ML sense. The "training" for such a device occurs during its design and manufacturing processes, where iterations and refinements are made to meet engineering specifications and regulatory requirements.

9. How the ground truth for the training set was established:

This concept is not applicable. Since there is no "training set" in the AI/ML context, there's no ground truth established for it. The "ground truth" for the device's design and manufacturing quality relies on engineering principles, material science, and adherence to quality management systems (e.g., 21 CFR Part 820 Quality System Regulation).

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The Legacy™ SMARTBase Abutment system is designed to be used in support of a dental implant(s) to provide support for prosthetic restorations in a partially edentulous patient. Legacy SMARTBase engaging abutments are intended for use in the mandible or maxilla in support of single unit restorations.

The Legacy SMARTBase Abutment system integrates multiple components for use in both a traditional and digital dentistry workflow: scan files from Intra-oral Scanners and lab scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories. The Legacy SMARTBase system consist of two major parts: the titanium base and zirconia top components make up a two-piece abutment.

• . Legacy SMARTBase abutment for narrow (3.2mmD) implants: Indicated for single-tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors.
• Legacy SMARTBase abutment for short (8mm) 3.7mmD implants: Indicated for tooth . replacement of mandibular and maxillary central and lateral incisors.

The Legacy SMARTBase Abutment is a two-piece engaging dental implant abutment comprised of a titanium base and a zirconia top (which can be supplied with the base or acquired separately by the customer). The abutments are offered in three widths (narrow, regular, and wide), platform diameters of 3.0mm, 3.5mm, 4.5mm and 5.7mm, and collar (titanium base) heights of 0.25, 1.0, and 2.0 mm in order to accommodate different patient anatomies. The device is supplied with fixation screws that function as an extension of the implant to which the SMARTBase is secured, and is used with several accessories in conventional and digital workflows to fabricate the patient-specific restorations, including scan adapters, implant analogs, and off-axis tools.

The Legacy SMARTBase Abutments allow for patient-specific designs through conventional and digital restoration materials and methods. The final restorations are designed and produced under the direction of a clinical professional and are based on requirements provided to Implant Direct or the preferred laboratory in digital or stone model form. The restoration (crown) is designed to fit on top of the SMARTBase abutment using off-the-shelf 3Shape software (K151455). The reference device, 3Shape Abutment Designer Software (product code PNP), provides the digital design as an accessory to the physical dental abutment. The CAD design requires loading of the Implant Direct abutment design library via the 3Shape server to the 3Shape Software in order to design the zirconia top component within the established design limitations and specifications. The 3Shape software provides a digital design output file that is used for fabricating the finished device.

The digital workflow includes the following products (not subject devices to this submission):

• Ceramic material: Zenostar MT ●
• Cement: EMBRACE Wetbond Resin Cement (K071278) ●
• Intra-oral scanner: 3M Tru-Definition (K122467), ITero Scanner (K131101) .
• Lab scanner: 3Shape D700 & 3Shape Scan-it Restoration Dental System (510(k) exempt, . product code NOF)
• . Abutment design software: 3Shape Abutment Designer™ Software (K151455)
• Milling machine: Wieland-Zenotec Select & Zenotec CAM .

The device is single-use and supplied non-sterilization by the end user. It is an externallycommunicating device which comes in permanent contact (>30 days) with a patient's tissue/bone.

This document describes Implant Direct Sybron Manufacturing, LLC's Legacy™ SMARTBase Abutments, a dental device intended to provide support for prosthetic restorations in partially edentulous patients. The FDA's 510(k) summary provides information on acceptance criteria and the studies performed to demonstrate substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific sample sizes used for each non-clinical test (mechanical fatigue, biocompatibility, sterilization validation). However, it mentions that dynamic fatigue testing was performed on "worst-case device configurations" per ISO 14801:2016.

• Test Set Sample Size: Not explicitly stated for each test, but "worst-case device configurations" were used for fatigue testing.
• Data Provenance: The studies are non-clinical (laboratory testing) performed internally by the manufacturer or by third-party labs following international standards (ISO) and FDA guidance. The country of origin of the data is not specified beyond being part of the manufacturer's submission to the FDA. The data is prospective as it was generated specifically for this 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not applicable as the studies are non-clinical, laboratory-based tests for physical, chemical, and biological properties of the device. There is no human "test set" requiring expert ground truth establishment in the context of diagnostic accuracy.

4. Adjudication Method for the Test Set

This information is not applicable as the studies are non-clinical laboratory tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "Clinical data is not needed to characterize performance and establish substantial equivalence. The nonclinical test data characterize all performance aspects of the device based on well-established scientific and engineering principles. Thus, clinical testing has not been conducted on this product."

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is geared towards AI/software performance. While software validation was performed for the associated CAD/CAM software, it is not an "algorithm only" performance study in the typical sense of AI diagnostics. The software (3Shape Abutment Designer Software) is a design tool for the abutment, not a standalone diagnostic or predictive algorithm. Its validation "ensured the ability of the system to scan the articulator and design the model to configure to the user's need to successfully create abutments." This implies a validation of its function within the design workflow, rather than a standalone performance metric for a decision-making algorithm.

7. The Type of Ground Truth Used

For the non-clinical tests:

• Mechanical Strength (Fatigue): Ground truth is established by the specified loads and cycles in ISO 14801:2016 and the equivalency standard to the predicate device. The "ground truth" is a pass/fail against these engineering standards.
• Biocompatibility: Ground truth is established by the pass/fail criteria defined in the referenced ISO 10993 series standards.
• Sterilization Validation: Ground truth is established by achieving a verified sterility assurance level of 10^-6 according to ISO 14947 and ISO 17665-1.
• Software Validation: Ground truth is established by the software's ability to "successfully create abutments employing 3Shape software within established design limitations and specification." This refers to functional correctness and adherence to design parameters.

8. The Sample Size for the Training Set

This document does not describe the development or training of an AI algorithm in the traditional sense, so there is no training set sample size mentioned. The CAD/CAM software mentioned (3Shape Abutment Designer Software) is an off-the-shelf product with an existing design library, not something that appears to have been "trained" by this manufacturer on a specific dataset.

9. How the Ground Truth for the Training Set Was Established

As there is no explicit training set for an AI algorithm described for the device itself, this question is not applicable. The software validation relies on the established functional specifications and design limitations of the 3Shape software and Implant Direct's abutment design library.

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The MOR™ implants are intended to be used for oral rehabilitation of edentulous and partially dentate patients in the maxilla and mandible to support single unit restorations. Implant retained restorations may consist of single crowns or bridges as well as complete or partial dentures. These implants are intended for delayed loading. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load. The MOR™ implants are only intended for use with straight abutments. The implant body is intended to be placed such no angle correction is necessary.

The PUR Implants are intended to be used for oral rehabilitation of edentulous and partially dentate patients in the maxilla and mandible to support single unit, and multiple unit retained restorations may consist of single crowns or bridges as well as complete or partial dentures. These implants are intended for delayed loading. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.

The PUR implants are only intended for use with straight abutments. The implant body is intended to be placed such no angle correction is necessary.

The MOR 3.0mm Implant System consists of 3.0mm endosseous dental implants. The MOR 3.0mm implant is a one-piece endosseous dental implant, manufactured of Titanium 6AL-4V ELI. The portion of the implant that is submerged in the bone is a treated roughened surface (blasted and etched) to facilitate osseointegration. The MOR 3.0mm implant is similar in design to the MOR 2.4mm implant previously cleared by FDA. The implant lengths are10mm, 13mm, 15mm, and 18mm. The implant has two prosthetic head design options - 0-ball identical to Sterngold MOR 2.4mm Implant (K153173), and a Tapered Abutment similar to the IMTEC MDI MII One Piece Implant 2.9mm (K081653). This implant has the same design threads as the MOR 2.4mm Implant. The MOR Implants will be provided "Sterile" using Gamma sterilization.

The PUR 3.2mm Implant System consists of 3.2mm threaded endosseous dental implants, as well as prosthetic components. The prosthetic components include a Straight Narrow Platform Slim Abutment with a 1.5mm and 3.0mm cuffs and a 0.050' Hex Prosthetic Screw. The purpose of the Slim Abutments is to provide surgical and prosthetic options for smaller spaces. They attach directly to the implant with the aid of the prosthetic screw and provide the transitional link between the head of the implant and the restorative components. These abutments are straight and not intended for angulation. The PUR Straight Slim Abutments are similar to FDA cleared PUR Straight Abutments Narrow and Regular Platforms 1.5mm and 3.0mm cuffs (K151928). The difference is the body of the proposed Straight Narrow Platform Slim Abutment is more tapered. The abutments and prosthetic screw are made of Titanium 6AL-4V ELI. The ancillary component is a 3.2mm cover screw, which is flush with the top surface of the implant to prevent tissue and bone from growing inside the implant. It is screwed onto the immediately after implant placement. It is made of Titanium 6AL-4V ELI. The PUR 3.2mm implant is an endosseous dental implant made of Titanium 6AL-4V ELI with a treated roughened surface (blasted and etched). The implant body is tapered with double-lead threads and10 start micro threads at the collar. The implant lengths are 8mm, 10mm, 12mm and 14 mm. This implant The PUR 3.2mm implant features the same prosthetic platform as the 3.5mm and 4.3mm implants already cleared by FDA (K151928). The purpose of the 3.2mm PUR implant is to provide surgical and prosthetic options for smaller spaces. The PUR 3.2mm Implants will be provided "Sterile" using Gamma sterilization.

This looks like a 510(k) summary for dental implants, which are hardware devices and do not utilize AI. As such, the requested information (acceptance criteria, study details, sample sizes, expert involvement, MRMC studies, standalone performance, ground truth, and training data) is not applicable to this document.

The document describes non-clinical performance testing for mechanical properties (torque) and sterilization/biocompatibility, which are standard for medical devices. The core of the submission is to demonstrate substantial equivalence to previously cleared predicate devices through direct comparison of material, design, and intended use.

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