(195 days)
A.B.DENTAL DEVICES® Dental Implants System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. A.B. DENTAL DEVICES® Dental Implants System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Two Stage Implants: 12, 15, 16BI.
One Stage: 16, 16b, 16B.
One Stage & One-Piece 3.0 mm diameter implants: 16, 16B1, are intended for placement at the mandibular central and lateral incisors and maxillary and lateral incisors. Indicated also for denture stabilization using multiple implants.
One stage & One-Piece 2.4 mm diameter implants for temporary use or long term use: 16, 16b, permit immediate splint stability and long term fixation of new or existing crown, bridge and prosthesis.
P14 Angulated Abutment Adapter is to be used with implant diameter 4.2mm and higher.
A.B. DENTAL DEVICES® Dental Implants System consists of one and two stage endosseous form dental implants, internal hexagonal and one piece implants system;
l2 - Screw Type Implant - Diameter 3.5, Length 8, 10,11.5,13,16
l5 - Conical Implant - Diameter 3.5, Length 8, 10,11.5,13,16
16 - Narrow Integral Implant - Diameter 2.4, 3, 3.2 Length 10, 11.5, 13, 16
l6b - Ball Attachment Implant - Diameter 2.4 Length 10, 11.5, 13, 16
16B - Narrow Implant - Diameter 3, 3.2 Length 10, 11.5, 13, 16
16BI - Narrow Implant - Diameter 3 Length 10, 11.5, 13, 16
Abutments System consists of healing caps, screws, Anti-rotation Abutment, Anatomic Anti-rotation Abutment, Narrow / Wide Anti-rotation Abutment, Zirconium Anatomic Abutment, Temporary PEEK Anatomic Anti-rotation Abutment, Long Angular Abutment 15°, Anatomic Angular Abutment 15°, Ball Attachment Abutment, Angular Ball Attachment 20°, Ball for Angular Adaptor, Titanium Sleeve, Anti-rotation Aesthetic Abutment, Composed Hex/Non Hex Abutment, Angular Adaptor, Locator and other superstructures; impression copy system & surgical instruments are also provided.
The provided text describes a 510(k) premarket notification for a medical device, specifically the "A.B. DENTAL DEVICES® Dental Implants System." This submission focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a clinical study.
Therefore, the document does not contain information about:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for a test set or data provenance for such a test.
- Number of experts, their qualifications, or adjudication methods for establishing ground truth in a test set.
- A multi-reader multi-case (MRMC) comparative effectiveness study, nor its effect size.
- A standalone (algorithm-only) performance study.
- Specific types of ground truth (e.g., pathology, outcomes data) for a test set.
- Sample size for a training set.
- How ground truth for a training set was established.
Instead, the document focuses on non-clinical testing and substantial equivalence.
Here's what can be extracted:
Acceptance Criteria and Device Performance (Based on Non-Clinical Testing)
The "acceptance criteria" here are compliance with recognized standards and demonstration of properties comparable to predicate devices, rather than performance metrics from a clinical study.
| Acceptance Criterion (Standard) | Reported Device Performance |
|---|---|
| ISO 7405 (Dentistry - Evaluation of biocompatibility of medical devices) | Complied. (Implied by the statement that the device "raises no new issues of safety or effectiveness than the predicate devices" after mentioning risk assessment and substantial equivalence which would encompass biocompatibility.) |
| ISO 5832-3 (Implants for surgery - Metallic materials - Wrought titanium alloy) | Implants are made of GR-5 Titanium Ti-6Al-4V ELI, which aligns with the standard. |
| ISO 14801 (Dentistry-Implants-Dynamic fatigue test for endosseous dental implants) | "A.B. DENTAL DEVICES® has conducted Fatigue - Static & Cycling tests which comply with ISO 14801... The test results have demonstrated the high resistance and high ability with the use of A.B. DENTAL DEVICES® Dental Implant System." The submission concludes that this "raises no new issues of safety or effectiveness than the predicate devices." |
| FDA guidance document: Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments | Complied. (Implied by the submission process and subsequent FDA clearance based on substantial equivalence, which assesses compliance with such special controls.) |
| Substantial Equivalence to Predicate Devices | The submission extensively details how the A.B. DENTAL DEVICES® Dental Implants System is similar or identical to several predicate devices (e.g., M.I.S, Alpha Bio Tec, IMTEC, Nobel Biocare, Biohorizon, Zimmer, Inclusive dental solutions, Zest Anchors) in terms of intended use, indications for use, technological characteristics (materials like GR-5 Titanium Ti-6Al-4V ELI, implant body contour, connection type), performance, and user interface. The conclusion states it "raises no new issues of safety or effectiveness than the predicate devices." |
Non-Clinical Study Details:
The study described is not a clinical study with patients, but rather bench testing to demonstrate mechanical performance and a risk assessment to demonstrate safety and effectiveness relative to predicate devices.
-
Sample size used for the test set and the data provenance: Not explicitly stated for each test, but the testing would have been conducted on representative samples of the A.B. DENTAL DEVICES® Dental Implants System. The provenance is internal to the manufacturer (A.B. DENTAL DEVICES Ltd., ISRAEL). This is retrospective in the sense that it's testing of manufactured devices for regulatory submission.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical tests is determined by the physical properties and performance against international standards, not expert consensus.
-
Adjudication method for the test set: Not applicable to mechanical bench testing.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done: No, not mentioned.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this is a physical dental implant system, not a software algorithm.
-
The type of ground truth used: For mechanical testing, the ground truth is established by the specified parameters and methodologies of the ISO standards (e.g., specific force, cycles, fracture points). For safety and effectiveness, the ground truth is the established safety profile and performance of the predicate devices.
-
The sample size for the training set: Not applicable, as this is not a machine learning algorithm.
-
How the ground truth for the training set was established: Not applicable.
In summary, the provided document details a substantial equivalence submission based on compliance with international standards for biocompatibility and mechanical fatigue, along with a comparison of the device's design and materials to legally marketed predicate devices. It does not contain information about clinical trials or performance metrics that would typically be associated with AI or diagnostic device studies.
§ 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.