(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 | Confirmatory endotoxin testing performed according to USP 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 ), 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.
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.