(446 days)
Alpha Dent Implants Dental Implants System is intended for surgical placement in the maxillary and/or mandbular 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.
The Alpha Dent Implants Dental Implants System consists of one or two stage endosseous form dental implants, internal hexagonal and one piece implants system. Abutments are used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation. The implantation procedure can be accomplished in a one-stage surgical operation for all implants type beside the INTEGRAL which is for one stage only. The system includes two-piece implant families: Active, Active Plus, and Classic, and a one-piece implant family: Integral. The system also includes prosthetic components such as healing caps, straight and angular abutments, titanium esthetic abutments, multi-unit abutments, ball attachments, and accessories.
The Alpha Dent Implants Dental Implants System has been assessed for acceptance criteria through a series of non-clinical tests.
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Material Biocompatibility | Biocompatibility cytotoxicity testing per ISO 10993-5 was performed and results were successful. The implants and prosthetic components are manufactured from Titanium alloy (Ti 6Al 4V ELI) complying with standard ASTM F 136. |
| Surface Morphology and Cleanliness | SEM and Surface analysis (EDS) after the anodize process demonstrated typical features of an anodized surface structure, and the morphology and cleanliness of the final product. The surface morphology and coating characterization are substantially equivalent to the predicate device K050705. |
| Sterilization Validation | Radiation Sterilization validation tests were conducted in compliance with ANSI/AAMI/ISO 11137-1:06 and EN ISO 11137-2:12. Test results demonstrated that a Sterility Assurance Level (SAL) of 10^-6 was achieved and all testing requirements were met. |
| Pyrogenicity | Pyrogenicity testing was performed according to USP using the LAL method on the sterile implants and met the acceptance criteria as required by USP and . |
| Shelf Life (Packaging Integrity) | Accelerated aging per ASTM-F-1980:07 was applied to the final sterile packaged product. Shelf life studies were completed by an independent testing laboratory in accordance with ISO 11607-1. Test results were successful and supported a 5-year shelf life for the sterilized products. Real-time shelf life studies are completed. |
| Dynamic Fatigue (Mechanical Performance) | Static and dynamic compression performance testing was conducted per ISO 14801:07 - Dentistry - Implants - Dynamic fatigue test for Endosseous Dental implants. The worst-case scenario (highest abutment angulation and lowest diameter implant) was tested. The test articles were able to withstand 5,000,000 cycles without failure at a substantially equivalent load to the cited predicate device. Comparative fatigue testing was conducted against a predicate device of similar intended use, size, and design. The results indicate substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify exact sample sizes for each of the non-clinical tests (biocompatibility, surface analysis, sterilization validation, pyrogenicity, shelf life, and fatigue testing). It generally refers to "test articles" being used. The data provenance is derived from non-clinical laboratory studies conducted by the manufacturer and an independent testing laboratory. The country of origin of the data is not explicitly stated, but the standards cited are international (ISO, ASTM, ANSI/AAMI).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable as the acceptance criteria and study detailed are based on objective non-clinical performance data and adherence to specified international standards, rather than expert judgment or interpretation of medical images or patient outcomes.
4. Adjudication Method for the Test Set
This section is not applicable as the acceptance criteria are based on objective measurements and adherence to pre-defined technical standards, not on subjective assessment or adjudication by multiple evaluators.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This is a non-clinical evaluation focusing on the physical and mechanical properties of the dental implant system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This section is not applicable as the device is a dental implant system, not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical tests was established through:
- International Standards: Adherence to specific requirements outlined in standards like ASTM F 136 (material), ISO 10993-5 (biocompatibility), ANSI/AAMI/ISO 11137-1, EN ISO 11137-2 (sterilization), USP , (pyrogenicity), ASTM-F-1980, ISO 11607-1 (shelf life), and ISO 14801:07 (fatigue testing).
- Predicate Device Equivalence: Performance was compared to legally marketed predicate devices, demonstrating "substantial equivalence" in terms of design, materials, and performance characteristics.
- Objective Measurements: Laboratory measurements such as microscopy for surface morphology (SEM), elemental analysis (EDS), and force/cycle counts for fatigue testing.
8. The Sample Size for the Training Set
This section is not applicable as the device is a dental implant system, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable for the same reason as above.
§ 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.