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510(k) Data Aggregation
(310 days)
Alpha Dent Implants Dental Implants System
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.
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(252 days)
Alpha Dent Implants Dental Implants System
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 dentulous 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.
The Alpha Dent Implant Active Conus (IAK), Implant Classic Conus (ICK), Implant Active Bio (IAB) Dental Implants System consists of one or two stage Endosseous form dental implants, with same platform of implant/prosthetics abutments connection- internal hexagon for anti-rotation and internal cone, and It is intended to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function.
The Alpha Dent Implants Dental Implants System is a medical device intended for surgical placement in the maxillary and/or mandibular arch to support crowns, bridges, or overdentures in edentulous patients. It aims to provide support for prosthetic devices (artificial teeth) and restore chewing function. The system is designed for single-tooth or multiple-teeth applications, with prostheses that can be screw or cement-retained to the abutment. It is also indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
The device's acceptance criteria and the study that proves it meets these criteria are detailed below:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Alpha Dent Implants Dental Implants System are primarily based on demonstrating substantial equivalence to predicate devices (K181138 and K180968) in terms of intended use, materials, performance, and safety. The performance criteria are derived from relevant international standards and the results of non-clinical testing.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance and Evidence |
|---|---|---|
| Intended Use | The device's intended use and indications for use should be substantially equivalent to previously cleared predicate devices. | The subject device's intended use and indications for use are previously cleared by FDA for the reference device K180968 (Alpha Dent Dental Implants Ltd) and are stated to be the same as the primary predicate K181138 (IS-III active System, Neobiotech Co., Ltd). |
| Materials | Implants and prosthetic components must be manufactured from medical-grade materials that comply with relevant standards. | Implants and abutments are manufactured from Titanium alloy (Ti 6Al 4V ELI) complying with ASTM F 136 Standard. This material is consistent with the predicate devices (Ti Grade 5 (Ti6AL4V-ELI) ASTM F136-13 for K180968 and Ti CP4 of ASTM F67 for K181138, though the subject device uses a higher grade Ti alloy). |
| Biocompatibility | The device must demonstrate biocompatibility for its intended use, in accordance with established biological evaluation standards. | Biocompatibility evaluation was conducted in accordance with ISO 10993-1 and FDA guidance. All biological endpoints were met, establishing the device as biocompatible. SEM and Surface analysis (EDS) after the anodize process demonstrated morphology and cleanliness. |
| Sterilization & Packaging | The device must be provided sterile (implants) with a minimum sterility assurance level (SAL) of 10⁻⁶, and packaging must maintain sterility for the specified shelf life. Non-sterile components (abutments) must have validated sterilization instructions for the end-user. | Implants are packaged in a clean room (ISO CLASS 7) and provided with a SAL of 10⁻⁶, validated per ANSI/AAMI/ISO 11137-1 and EN ISO 11137-2. Accelerated aging per ASTM-F-1980 was applied to substantiate a 5-year shelf life, with a real-time study ongoing. Abutments are supplied non-sterile, and moist heat sterilization for end-users was validated per ANSI/AAMI/ISO 17665-1, demonstrating a 6-log reduction of Geobacillus stearothermophilus. |
| Pyrogenicity | The device must meet pyrogen limit specifications. | LAL Endotoxin Analysis demonstrated pyrogenicity met specifications, with a testing limit of 20 EU/device, based on USP . |
| Mechanical Performance | The implants must withstand dynamic fatigue loads per ISO 14801, demonstrating sufficient mechanical strength and durability. Performance should be comparable to the predicate device. For prosthetic components, the implant-abutment connection design and general shape should be similar to recognized predicate devices. The thread type variation for internal thread should not affect structural performance and offer same pitch design. | Static and dynamic compression performance tests were conducted per ISO 14801. The worst-case scenario (smallest diameter, longest implant, 25° abutment) was selected. The measured fatigue limits for Alpha Dent implants were similar to those of the predicate device Neobiotech (K181138) (metal dental implants with a diameter of 3.5 mm). The run-out bending moment was within similar values. The implant/abutment connection design, general shape, and dimensions are compared to predicate K180968. The difference in internal thread type (M1.80-6H vs 1-72 UNF 2B) was deemed not to affect structural performance as both have identical outer diameter (1.80 mm) and same pitch design. |
| Design/Technological Characteristics | The device's technological characteristics, including implant/abutment connection design, surface treatment, general shape, and dimensions, should be comparable to predicate devices. | The implant/abutment connection design (internal hexagon for anti-rotation and internal cone) is stated to be the same as the primary predicate (K181138). The surface treatment (anodized layer), general shape, and dimensions are substantially equivalent to the reference predicate (K180968). While there is a slight difference in design and dimensions between the primary predicate and the subject device, and a minor difference in internal thread type, these were considered not to affect structural performance. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific "sample size" in terms of number of devices for each non-clinical test (e.g., how many implants were subjected to fatigue testing). It generally refers to "the implant used in the testing was the smallest in diameter and the longest in length available with this system of implants," indicating a worst-case selection for mechanical performance.
The data provenance is from non-clinical bench testing conducted by Alpha Dent Implants GmbH, not from human or animal subjects. Therefore, there is no information on country of origin of data, or whether it was retrospective or prospective in the sense of clinical studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable. The "test set" in this context refers to non-clinical bench testing data and engineering analysis, not clinical data requiring expert review for ground truth establishment. Equivalence is established through comparison to predicate devices and adherence to international standards.
4. Adjudication Method for the Test Set
This question is not applicable. There was no "test set" of clinical cases requiring adjudication by experts. The substantiation relies on engineering judgment, comparison to predicate devices, and demonstrated compliance with recognized standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. The document explicitly states: "No clinical studies were performed." This is a 510(k) submission primarily relying on substantial equivalence to legally marketed predicate devices through non-clinical performance testing and comparative analysis of design and materials.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
This question is not applicable. The Alpha Dent Implants Dental Implants System is a physical medical device (dental implants and associated prosthetic components), not an AI algorithm or software. Therefore, there is no "standalone" algorithm performance to assess.
7. The Type of Ground Truth Used
The "ground truth" for demonstrating the safety and effectiveness of the device is established by:
- Substantial Equivalence to Predicate Devices: Comparing the new device's intended use, technological characteristics (design, materials, surface treatment), and performance data to those of one or more legally marketed predicate devices (K181138 and K180968) that have already been determined safe and effective.
- Adherence to Recognized International Standards: Compliance with standards such as ASTM F 136 (material), ISO 10993-1 (biocompatibility), ANSI/AAMI/ISO 11137-1 and EN ISO 11137-2 (sterilization), USP (pyrogenicity), ASTM-F-1980 (accelerated aging/shelf life), and ISO 14801 (dynamic fatigue test for implants).
8. The Sample Size for the Training Set
This question is not applicable. There is no "training set" in the context of this device submission, as it is a physical medical device and not an AI/ML algorithm.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the same reason as point 8.
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