(310 days)
Alpha Dent Implants Dental Implants System is intended for surgical placement in the maxillary and/or the mandibular arch, to support crowns, bridges, or over dentures, in edentulous patients. It is intended to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function. The System is intended to be used in either single tooth or multiple teeth applications. The prostheses can be screw or cement retained to the abutment.
The Alpha Dent Implants Dental Implants System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Superior Active and Active Bio Plus are a conical-shaped implant with a helical aggressive thread. It is used under one- or two-steps procedure in all bone types. The implant has a platform with an inner cone and a hexagon for positioning.
Superior Active and Active Bio Plus consist of the implant itself and a cover screw, which are packed in a titanium cuff filled with isotonic sodium chloride solution and a plastic flask.
The implant surface treatment method, known as Sandblasted, Large Grit, Acid-Etched (SLA), is a technique designed to roughen the surface of dental implants. The SLA process consists of two key steps: sandblasting with large grit particles to create a roughened texture, followed by acid etching to refine the surface.
The implant WET packaging process involves placing the implant in a protective titanium sleeve within a vial filled with NaCl 0.9% solution. The vial is sealed with a lid and placed inside a blister package. Both the plastic vial and the blister package serve as sterile barriers.
Additional abutments to the already submitted abutments in K210499: The abutments are anodized. Healing caps for implants with conical connection and Anatomical Titanium Shoulder Abutments and Healing caps for Multi-Unit System are also described.
This document pertains to a 510(k) submission for the Alpha Dent Implants Dental Implants System (K240435). It details the device, its intended use, and a comparison to predicate devices to establish substantial equivalence.
Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance data. It explicitly states: "No clinical studies were performed." Therefore, there is no information about a "study that proves the device meets acceptance criteria" in terms of clinical performance, sample sizes for test sets in clinical trials, experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, as these typically relate to clinical efficacy/effectiveness or AI/software performance, neither of which are the primary focus of this specific 510(k) for a dental implant system.
The "acceptance criteria" discussed below are related to the non-clinical performance testing conducted to support the substantial equivalence claim.
Acceptance Criteria and Device Performance (Non-Clinical)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Standard | Acceptance Criteria | Reported Device Performance (Summary) |
|---|---|---|---|
| Mechanical Strength | ISO 14801:2016 Dentistry — Implants Dynamic loading test for endosseous dental implants | Subject device (IABP & ISPA) performance must be substantially equivalent to predicate devices. | Mechanical strength testing was conducted on "worst-case scenario" (25-degree abutment angulation, 3.3mm diameter implant). Results indicated substantial equivalence to predicate devices. |
| Surface Cleanliness/Biocompatibility | SEM/EDX analysis for cleanliness; ISO 10993-1:2018 (Biological evaluation of medical devices); USP / ANSI/AAMI ST72 (Pyrogenicity) | No harmful alumina or chemicals remaining on implant surface; Biocompatibility per ISO 10993-1; Pyrogen limit of 20 EU/device (LAL method). | SEM/EDX showed no harmful residues, only slight NaCl traces. Biocompatibility (cytotoxicity) conducted per ISO 10993-5 (including aged implants) confirmed no adverse effects. Pyrogenicity testing met the 20 EU/device limit. |
| Hydrophilicity | Contact angle measurements (standardized water drop test with isotonic saline); Qualitative observation of droplet distribution rate | Contact angle below 90° for hydrophilicity; smaller angle for greater wettability. | Non-aged implant: 34° contact angle (hydrophilic). 2-year-aged implant: 0° contact angle (complete wetting, maximal hydrophilicity). Rapid spread of droplet observed. |
| MR Compatibility | FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment" | Magnetically induced displacement force and torque suitable for MRI environment. | Non-clinical worst-case MRI review performed based on scientific rationale and published literature. Rationale addressed parameters per FDA guidance. |
| Packaging Integrity | ISO 11607-1:2019, Packaging for terminally sterilized medical devices | Packaging must maintain sterility and product integrity. | Packaging performance testing conducted according to ISO 11607-1. |
| Sterilization Validation | ANSI/AAMI/ISO 11137-1 and EN ISO 11137-2 | Sterility Assurance Level (SAL) of 10^-6 must be achieved. | Test results demonstrated SAL of 10^-6 was achieved and all testing requirements were met. |
| Shelf Life | ASTM-F-1980 (Accelerated Aging) | Packaging integrity, cytotoxicity, and hydrophilicity maintained over claimed shelf life. | Accelerated aging completed for 2-year shelf-life claim. Extended 5-year study ongoing based on these criteria. |
Study Details (Non-Clinical Performance Testing)
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the exact number of units tested for each non-clinical test (e.g., how many implants were tested for mechanical strength, how many samples for SEM/EDX, etc.). It states that "worst-case scenario" samples were tested for mechanical strength (e.g., "Implant Active Bio Plus (IABP)3.3x13 and Implant Superior Active(ISPA)3.5x13, along with Angulated Titanium Abutment 25 ° angulation").
The data provenance is from non-clinical laboratory testing conducted by the manufacturer (Alpha Dent Implants GmbH, based in Germany) or outsourced laboratories, as part of the 510(k) submission process. This is retrospective in the sense that the testing was performed before the submission for premarket review.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable in the context of this 510(k) submission. "Ground truth" established by experts in this context would typically refer to clinical or diagnostic evaluation (e.g., radiologist reads for AI models), which are explicitly stated as "No clinical studies were performed." The "ground truth" for the non-clinical tests are objective measurements based on established engineering and materials science standards (e.g., forces measured, chemical analysis).
4. Adjudication Method for the Test Set:
Not applicable, as this refers to clinical evaluation or expert consensus, not non-clinical performance testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No. The document explicitly states "No clinical studies were performed." Therefore, no MRMC study was conducted or reported.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a dental implant system, not a software algorithm or AI.
7. The Type of Ground Truth Used:
The "ground truth" for the non-clinical performance testing is based on objective measurements from laboratory tests against established industry standards (e.g., ISO, ASTM, USP). For example, mechanical strength is measured against the failure loads defined by ISO 14801, surface properties are observed and measured via SEM/EDX and contact angle, and biocompatibility is assessed by established protocols like ISO 10993.
8. The Sample Size for the Training Set:
Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set was Established:
Not applicable. This is not an AI/ML device.
§ 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.