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510(k) Data Aggregation
(280 days)
The Paltop Dental Implant System Internal Hex Standard and Wide Platforms implants (implant diameters 3.75 and above and lengths 8mm and above) as well as Conical Connection implants (implant diameters 3.75 and above and lengths 8mm and above), are indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. The Paltop Dental Implant System is indicated also for immediate loading, when good primary stability is achieved and with appropriate occlusal loading.
The Paltop Narrow Implant (Internal Hex and Conical Connections, for implant diameters 3.25 and lengths 10mm and above) is indicated for use in surgical and restorative applications for placement in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws where the interdental spaces are limited by the adjacent teeth and roots, to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. The Paltop Narrow Implant is indicated also for immediate loading, when good primary stability is achieved and with appropriate occlusal loading.
The purpose of this submission is to add components and update previously cleared to the Paltop Advanced Dental Solutions, Ltd product line of endosseous dental implants, abutments, and prosthetic components. Specifically, this submission seeks marketing clearance for dental implants with body diameters of 3.25 mm, 3.75 mm, 4.2 mm, 5 mm, and 6 mm various compatible abutments, two (2) cover screws, and one (1) additional abutment screw.
The subject device dental implants are self-tapping, threaded, root-form dental implants intended for the functional and aesthetic rehabilitation of the partial or fully edentulous mandible or maxilla. Once osseointegrated, the implants act as an anchor for various fixed or removable prosthetic solutions. All subject device implants are intended to be placed at the bone level (crestal position). All implants with diameters of 4.2 mm and 5.0 mm diameters allow for the option of platform switching.
Advanced, Advanced +, Dynamic, PAI, and PAI TC dental implants have an internal hex connection. Each implant line is provided with a body diameter of 3.25 mm, and interface with the Paltop Narrow Platform (NP) prosthetic components, with an interface diameter of 2.90 mm. Implants with the 3.25 mm body diameter are provided in lengths of 10, 11.5, 13, and 16 mm. Each implant line also is provided with body diameters of 3.75, 4.2, and 5 mm; these implants are provided in lengths of 8, 10, 11.5, 13, and 16 mm and interface with the Paltop Standard Platform (SP) prosthetic components, with an interface diameter of 3.65 mm.
The Advanced +, Dynamic, PAI, and PAI TC dental implant lines also are provided in a body diameter of 6 mm, in lengths of 8, 10, 11.5, 13, and 16 mm. Implants with the 6 mm body diameter interface with the Paltop Wide Platform (WP) prosthetic components, with an interface diameter of 4.4 mm. The Advanced +, Dynamic, PAI, and PAI TC dental implants have an internal threaded section (UNF 1-72) for connection to the corresponding cover screw, healing cap, abutment, or abutment screw.
The subject device conical connection implants (Dynamic Conical MC, and PCA) are provided in body diameters of 3.25, 3.75, 4.2, and 5 mm. Conical implants with the 3.25 mm body diameter are provided in lengths of 10, 11.5, 13, and 16 mm; all other body diameter sizes are provided in lengths of 8, 10, 11.5, 13, and 16 mm. All conical implants have a recessed internal section for abutment indexing, and an internal threaded section for connecting with corresponding compatible healing caps, abutments, and screws. Subject device implants with a conical geometry connect to conical connection prosthetic components. The conical connection prosthetic interface diameter is 2.9 mm.
The subject device conical connection implants (Dynamic Conical MC, and PCA) have a recessed 22° internal conical taper and a section for abutment indexing, as well as a threaded section (M1.6 x 0.35) for connection to the corresponding cover screw, healing cap, abutment, or abutment screw.
All subject device titanium abutments and screws are manufactured from titanium alloy conforming to ASTM F136.
The subject device endosseous dental abutments provide a range of cement-retained and screw-retained prosthetic solutions for dental implant restoration. Subject device abutments include seven (7) compatible implant abutment designs: Healing Caps, Straight Abutments, Angulated Abutments, Multi-Unit Abutment, Temporary Abutments, Snap-On Abutment System (SAS), and Ball Abutments for subject and non-subject device implants of the same families (Advanced, Advanced +, Dynamic, PAI, and PAI TC dental implants) and the conical healing caps are compatible with conical subject and non-subject devices (PCA, Dynamic Conical, Dynamic Conical MC). Abutments are offered in either indexed (engaging) or non-indexed (non- engaging) external connections that are compatible with the subject device implants.
Subject device abutments are compatible with the subject device implants with the internal hex connection, and the conical connection implants (subject device healing cap), as well as previously cleared compatible implants as described in Table 4 Subject Device Component Compatibilities. Subject device abutments are compatible with subject device implants according to their appropriate internal connection and platform. Subject device implants with an internal hex connection and diameter size of 3.25 mm (Advanced, Advanced +, Dynamic, PAI, and PAI TC) are compatible with subject device Narrow Platform (NP) Abutments, as well as abutments cleared in K210117. Subject device implants with an internal hex connection and diameter size of 3.75 mm, 4.2 mm and 5.0 mm (Advanced, Advanced +, Dynamic, PAI, and PAI TC) are compatible with subject device Standard Platform (SP) Abutments, as well as abutments cleared in K232740. The 6.0 mm diameter internal hex implants of all lengths (Advanced +, Dynamic, PAI, and PAI TC) are compatible with subject device Wide Platform (WP) Abutments, as well as abutments cleared in K232740. Subject device implants with a conical connection (Dynamic Conical MC and PCA) are compatible with the subject device conical connection healing cap, as well as conical connection abutments cleared in K220200. The 5.0 mm diameter conical connection implants of all lengths (Dynamic Conical MC and PCA) are compatible with conical connection abutments cleared in K232740.
All subject device titanium abutments and screws are manufactured from titanium alloy conforming to ASTM F136.
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(258 days)
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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(121 days)
The Paltop Conical Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. Narrow diameter implants are intended for placement in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws where the horizontal space is limited by the adjacent teeth and roots. The Paltop Conical Implant System is also indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
The Paltop Conical Implant System which comprises endosseous root-form dental implants, mating abutment screws, and other associated components for single-unit, multi-unit, and overdenture restorations. 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 Conical Implant System implants are one- and two-stage endosseous screw type dental implants with associated compatible abutments, screws, and other associated accessory components. The Paltop Conical Implant System prosthetic components include healing caps, and multi-unit abutments which are available in straight or angulated configurations. Prosthetic devices used with the dental implant abutments in this submission may be screw-retained or cemented. The implants, titanium abutment screws are fabricated from a Titanium-6 Aluminum 4 Vanadium ELI titanium alloy (Grade 23) which conforms to ASTM F136, Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). The Subject device implants are surface treated with SLA (Sand-blasted, Large Grit, Acid Etched). Immediate temporary abutments include a PEEK (Polyether ether Ketone) material sleeve, and the SAS abutment includes a PEEK healing cap/coping. All implants and prosthetic components are one-time use device components are provided sterile and sterilized by gamma irradiation except for Single-Unit and Multi-Unit copings, SAS Abutment components and all replacement screws which are provided non-sterile. Devices provided as non-sterile are sterilized by steam.
The provided text describes the 510(k) submission for the "Paltop Conical Implant System." This document is a regulatory filing demonstrating substantial equivalence to previously cleared devices, not a study performing clinical validation against acceptance criteria for a new AI/CADx device.
Therefore, most of the requested information (acceptance criteria for clinical performance, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, ground truth establishment, etc.) is not present in this document, as it pertains to a different type of device and regulatory submission.
The document focuses on non-clinical performance testing (fatigue testing, biocompatibility, endotoxin testing, sterilization validation, and MRI compatibility) to demonstrate the device's mechanical and material properties are equivalent to the predicate devices.
However, I can extract the information that is present and explicitly state what is missing based on the document's content:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative clinical performance acceptance criteria (e.g., sensitivity, specificity, AUC) because it's a dental implant, not a diagnostic AI device. Instead, it refers to non-clinical performance standards.
| Acceptance Criterion (Non-Clinical, General) | Reported Device Performance |
|---|---|
| Fatigue testing (per ISO 14801:2016) | Performed according to requirements. "demonstrate suitability for intended use." |
| Material Biocompatibility (per ISO 10993-1, 10993-5) | Leveraged from predicate devices. "support suitable biocompatibility." |
| Endotoxin testing (per USP<85> and USP<161>) | Performed. "conformance with testing requirements." |
| Sterilization validation | Leveraged from predicate devices. "demonstrate suitable sterilization of the Subject device sterile components." |
| MRI compatibility | Reviewed using scientific rationale and published literature. "addressed parameters per the FDA guidance." |
| Design and Dimensions (Equivalence to Predicates) | "Slight differences in design dimensions do not affect the intended use of the device and are mitigated or supported through non-clinical performance testing results." |
2. Sample sized used for the test set and the data provenance
- Test Set Sample Size: Not applicable. This document refers to non-clinical bench testing (e.g., mechanical fatigue, material properties), not a clinical trial with a test set of patient data.
- Data Provenance: Not applicable for a clinical test set. The non-clinical testing appears to be conducted by the manufacturer, Paltop Advanced Dental Solutions, Ltd.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. No clinical ground truth was established as this was a 510(k) submission for a physical device, based on non-clinical testing and substantial equivalence to predicate devices.
4. Adjudication method for the test set
- Not applicable. No clinical test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- No. This type of study is for evaluating medical imaging AI. This document is for a dental implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI algorithm.
7. The type of ground truth used
- Not applicable for clinical ground truth. The "ground truth" for this device's performance validation is based on engineering standards, material specifications, and regulatory guidelines (e.g., ISO 14801 for fatigue, ISO 10993 for biocompatibility).
8. The sample size for the training set
- Not applicable. There is no AI training set.
9. How the ground truth for the training set was established
- Not applicable. There is no AI training set.
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(315 days)
The Paltop Narrow Implant is indicated for use in surgical and restorative applications for placement in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws where the horizontal space is limited by the adjacent teeth and roots, to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. The Paltop Narrow Implant is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
This submission expands the Predicate Narrow Implant device to include 3.0 mm diameter implants, additional implant thread configurations and additional prosthetic components to the previously cleared Paltop Narrow Implant (K130462).
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.
Paltop Narrow Implant are one- and two-stage endosseous screw type dental implants with associated abutments. The implants, titanium abutment screws are fabricated from a Titanium-6 Aluminum 4 Vanadium ELI titanium alloy which conforms to ASTM F136. The Paltop Narrow Implants are surface treated with SLA (Sand-blasted, Large Grit, Acid Etched).
The implants are available in three thread/body configurations: Advanced, Advanced+, and Dynamic. The Advanced, Advanced+ and Dynamic implants have micro threads at the neck. All implants have a parallel coronal and mid-section area with an apical taper. The families have slight differences in thread profile and either a passive or active apex. The 3.0 mm diameter implants are prosthetically compatible with the previously cleared Paltop Narrow Implant (K130462) prosthetic devices.
This submission introduces Single-Unit Abutments for the Paltop Narrow Implant device. The submission replaces the original straight Multi-Unit Abutments from the K130462 submission and includes additional gingival heights. The submission also introduces an angulated Multi-Unit titanium abutment, all compatible with the Paltop Narrow Implant device. The submission expands the compatible prosthetic components to include new temporary titanium abutments and healing caps compatible with Single-Unit and Multi-Unit titanium implant abutments.
The Subject device implants may be used with the Predicate device abutments previously cleared under K130462, based on non-clinical performance bench testing provided in this submission.
The Subject device abutments may be used with the Predicate device implants previously cleared under K130462, based on non-clinical performance bench testing provided in this submission. The only exception is the implant cover screw (P/N 80-70100) which is specific to the 3.0 mm diameter implants in this submission.
The Subject device Multi-Unit Abutment components such as copings/interfaces, temporary abutments, cylinders, and screws may be used with the Predicate device Multi-Unit Abutments previously cleared under K130462 based on non-clinical performance bench testing provided in this submission.
All implants and prosthetic components are one-time use devices. All Subject devices in this submission are provided sterile and sterilized by gamma irradiation except for Single-Unit and Multi-Unit copings and all replacement screws which are provided non-sterile. Devices provided as non-sterilized by steam.
Here's a breakdown of the acceptance criteria and the study information for the Paltop Narrow Implant, based on the provided document.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria in a table format for specific performance metrics like fatigue life or bone-to-implant contact percentages. Instead, it refers to industry standards and general outcomes. The reported device performance is presented narratively.
| Performance Characteristic | Acceptance Criteria (implied/standards referenced) | Reported Device Performance |
|---|---|---|
| Fatigue Strength | Conformance to ISO 14801:2016 for dynamic loading | Successfully tested to ISO 14801:2016. Worst-case scenario chosen. |
| Biocompatibility | Suitable biocompatibility | Demonstrated suitable biocompatibility based on review of published literature, internal routine monitoring data, and post-market surveillance data. |
| Osseointegration | Successful osseointegration, industry-accepted bone level changes | 92% of implants showed bone level improvement or maintenance; bone level decreases less than 1mm; 100% met criteria for successful osseointegration. |
| Implant Survival Rate | Failure rates below industry levels | Post-market surveillance indicated failure rates below industry levels. |
| Residual Aluminum Particles | No negative impact on osseointegration and implant survival | Evaluation supported previous findings that residual aluminum particles (if present) from specific surface treatment do not negatively impact osseointegration and implant survival. |
| Endotoxin Levels | Conformance to USP <161> | Confirmatory endotoxin testing performed according to USP <161> acceptance criteria. |
| Sterilization (Sterile Components) | Suitable sterilization | Demonstrated suitable sterilization based on predicate/reference device validations. |
| Sterilization (Non-Sterile Components) | Suitable sterilization (cleaning validation, ISO 17665-1) | Cleaning validation and sterilization per ISO 17665-1 performed for non-sterile components and components requiring subsequent sterilization. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a test set sample size for each specific non-clinical test in terms of a number of devices. It refers to general testing.
- For the bone changes evaluation (part of biocompatibility/osseointegration): "A total of 174 surfaces were graded (87 implants)."
- Data provenance: The bone changes evaluation references "published literature" on patients, suggesting retrospective (or possibly prospective clinical studies mentioned in the literature). "Internal routine monitoring data" and "post-market surveillance data" are mentioned, indicating real-world data collection, likely retrospective for surveillance and ongoing for monitoring. The manufacturer is Paltop Advanced Dental Solutions, Ltd, Hashita 5, Industrial Park, Caesarea 3088900, Israel.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document doesn't specify the number or qualifications of experts used to establish "ground truth" for the test set. For the bone level evaluation, it states "Mesial and distal surfaces were examined and graded." It is implied that these evaluations were done by qualified clinical professionals as part of the published literature or internal monitoring, but no specific details are provided.
4. Adjudication Method
No adjudication method is mentioned for any of the evaluations (e.g., bone level grading, or evaluation of non-clinical tests). The document implies acceptance based on test results meeting standards or being comparable to predicate devices.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned. This device is an endosseous dental implant, not an AI diagnostic tool, so an MRMC study comparing human readers with and without AI assistance is not applicable.
6. Standalone Performance Study
The primary studies detailed are "non-clinical bench performance testing." This refers to laboratory testing of the device itself (fatigue, pull-out, etc.) and biological evaluations based on literature review and historical data, which are "standalone" in the sense that they assess the device's physical and biological properties. There is no human element being assessed.
7. Type of Ground Truth Used
The ground truth used several types:
- Industry Standards: For fatigue testing (ISO 14801:2016), endotoxin testing (USP <161>), and sterilization (ISO 17665-1).
- Clinical Outcomes Data: For osseointegration and implant survival (from published literature and post-market surveillance). This includes "bone level improvement or maintenance" and "failure rates below industry levels."
- Analytical Data: SEM/EDS data for residual particles.
- Comparison to Predicate/Reference Devices: Demonstrating similarity in design and performance to already cleared devices.
8. Sample Size for the Training Set
The document does not mention a "training set" or "training data" in the context of an algorithm or AI. This is a medical device (dental implant) that undergoes physical and biological performance testing, not a machine learning model.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an algorithm described in this document.
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