(175 days)
Biodenta dental implants are intended for surgical placement in mandibles or maxillae to support single or multiple tooth restorations or terminal or intermediate abutment support for fixed or removable bridgework and to retain overdentures. They are intended for delayed loading.
The Biodenta Dental Implant System - Bone Level Tapered D3.0 and L6.5 mm is an integrated system of endosseous dental implants, which are designed to support prosthetic devices for partially or fully edentulous patients. The system consists of a variety of dental implants, abutments, prosthetic parts and related surgical instruments. The Bone Level Tapered D3.0 and L6.5 mm implants use the same platforms and abutment connections like the Bone Level D 3.0 to 6.0 (K123512). Therefore the abutments and prosthetic parts which are compatible to the Bone Level D 3.0 to 6.0 (K123512) are also compatible to the predicate device.
The submission includes:
- Diameter 3.0 mm Implants with Length of: 10, 12, and 14 mm; Platform B0
- Diameter 4.1, 4.8, and 6,0 mm Implants with Length of: 6.5 mm; Platform B2
The provided text describes a 510(k) summary for the Biodenta Dental Implant System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with performance metrics.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies is not applicable in this context, as the submission relies on non-clinical testing and comparison to predicate devices, not on a clinical performance study with acceptance criteria.
However, I can extract the non-clinical testing data that was used to support the safety and effectiveness for equivalence:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: The device should have sufficient mechanical strength for the intended clinical application and its surface area/bone to implant contact area should be sufficient compared to predicate devices.
- Reported Device Performance:
- Dynamic Fatigue Testing: The subject device (Biodenta Dental Implant System - Bone Level Tapered D 3.0 and L 6.5 mm) was found to be "identical" to the predicate device (Biodenta Dental Implant System - Bone Level D 3.0 to 6.0 mm, K123512) and thus has "sufficient mechanical strength for the intended clinical application."
- Surface Area and Bone to Implant Contact Area: The Biodenta implant's surface area and bone to implant contact area were calculated to be "larger than the predicate device's surface area and bone to implant contact area." Therefore, the surface area and bone to implant contact area are "considered to be sufficient."
2. Sample size used for the test set and the data provenance: Not applicable. The testing described is non-clinical (dynamic fatigue, CT scan modeling).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for non-clinical tests is based on established engineering standards (e.g., ISO 14801:2007) and calculations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI/medical imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the non-clinical tests:
* Dynamic fatigue testing: Conformance with ISO 14801:2007 standard.
* Surface area and bone to implant contact area: Calculated from 3D models generated from CT scans, compared against predicate devices.
8. The sample size for the training set: Not applicable. This is not a machine learning or AI device.
9. How the ground truth for the training set was established: Not applicable.
§ 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.