(135 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.
The Biodenta Dental Implant System - Bone Level D 3.0 to 6.0 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, prosthetic parts and related surgical instruments. The Bone Level D 3.0 to 6.0 mm implants use the same platforms and abutment connections like the Bone Level implants (K111003) for the diameter 4.1. 4.8. and 6.0 mm implants, and therefore the abutments and prosthetic parts of the Bone Level implants are used. The diameter 3.0 mm implants use the same connection concept in a narrower version. The submission includes:
- Diameter 3.0 mm Implants with Length of: 10, 12, and 14 mm; Platform B0
- Diameter 4.1 and 4.8 mm Implants with Length of: 6.5 mm; Platform B2
- Diameter 6.0 mm Implants with Length of: 6.5, 8, 10, and 12 mm; Platform B2
- Straight abutments (Straight, Temporary, Ball, Locator); B0 platform, Length 10.4 14.9 mm, Diameter 3.6 - 4.0 mm
- Healing abutments, closure screws; B0 platform, Height 0.5 7.1 mm, Diameter 2.8 3.9bmm
The provided text describes a 510(k) Pre-market Notification for the Biodenta Dental Implant System - Bone Level D 3.0 to 6.0 mm. This submission focuses on demonstrating substantial equivalence to predicate devices, primarily through non-clinical testing. Therefore, it does not involve a study with acceptance criteria and reported device performance in the typical sense of a diagnostic or AI-driven device.
Here's an analysis of the provided information based on your requested criteria, highlighting what is present and what is not:
Acceptance Criteria and Study for Biodenta Dental Implant System - Bone Level D 3.0 to 6.0 mm
This 510(k) submission primarily relies on non-clinical testing to demonstrate the substantial equivalence of the Biodenta Dental Implant System to previously marketed predicate devices. The "acceptance criteria" here are defined by the performance in these non-clinical tests, ensuring the device meets safety and effectiveness standards comparable to its predicates.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Non-Clinical) | Reported Device Performance |
|---|---|
| Mechanical Strength (Fatigue Testing): Sufficient mechanical strength for intended clinical application as per FDA Guide: Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments. | The results show that the Biodenta Dental Implant System - Bone Level D 3.0 to 6.0 mm has sufficient mechanical strength for their intended clinical application. (Worst-case scenario tested). |
| Surface Area Comparison: Implant surface area of the new device should be almost identical or higher than the predicate device surface area. | All Biodenta Dental Implant System - Bone Level D 3.0 to 6.0 mm implant's surface areas are almost identical or higher than the predicate device surface area. Therefore, the surface area is considered sufficient. |
Regarding the other requested information (primarily relevant for AI/diagnostic studies):
- 2. Sample size used for the test set and the data provenance: Not applicable. No clinical test set data is presented. The testing pertains to physical device properties.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" in the diagnostic sense is established for this type of device submission. Performance is based on engineering tests.
- 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 a medical device (dental implant), not an AI diagnostic tool.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device, not an algorithm.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of an AI/diagnostic device. The "truth" for this device is its adherence to mechanical performance standards and material specifications, demonstrated through laboratory testing.
- 8. The sample size for the training set: Not applicable. There is no "training set" for a physical dental implant.
- 9. How the ground truth for the training set was established: Not applicable.
Summary of Approach:
The Biodenta Dental Implant System's 510(k) submission demonstrates substantial equivalence primarily through non-clinical test data. This involved:
- Fatigue testing: Conducted according to FDA guidance for root-form endosseous dental implants and abutments. This test assessed the mechanical strength under worst-case scenarios, proving it is sufficient for the intended clinical application.
- Surface area analysis: Compared the implant surface area of the new device to predicate devices, finding it to be almost identical or higher, which is deemed sufficient.
The submission explicitly states: "Non-clinical test data was used to support the decision of safety and effectiveness." No clinical testing was presented in this summary to support the substantial equivalence. The "acceptance criteria" were met by successfully passing these specified non-clinical performance benchmarks.
§ 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.