A.B. Dental Devices Dental Implants System

• K Number: K181381
• Device Name: A.B. Dental Devices Dental Implants System
• Manufacturer: A.B Dental Device Ltd.
• Date Cleared: 2018-11-23 ( 183 days)
• Product Code: NHA
• Regulation Number: 872.3630
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: K132125 , K112440 , K162482

Intended Use

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.

Device Description

A.B. DENTAL DEVICES® Dental Implants System consists of one and two stage endosseous form dental implants, internal hexagonal and one piece implants systems. Narrow platform implants are to be used with straight abutments only. The following components are being added:

• . P0-3 narrow platform healing caps, 4 and 7 mm length
• PON-3.75 standard platform, narrow healing caps, 4 and 7 mm length .
• P3-5 standard platform, straight abutment, 5 mm diameter, 5 mm length ●
• P3S-3 narrow platform, anatomic, straight abutment, 1, 2, 3 mm shoulder lengths
• . P3SW-3.75 standard platform, anatomic, straight abutment, wide diameter, 1, 2, 3 mm shoulder lengths
• P3W-3 narrow platform, straight abutment, wide diameter, 9 mm length
• P5-3 narrow platform, ball attachment, 4, 5, 6 mm height
• P5-3.75-20 standard platform, 20º ball attachment, 4 and 6 mm height ●
• P9HG-3.75 standard platform, composed abutment, gold alloy
• P9R and P9HR -3.75 standard platform, composed abutment, CoCr alloy
• . P25-3 narrow platform, A.B. LOC abutments, 0, 1, 2, 3, 4 5 mm height
• . P25-3.75 standard platform. A.B. LOC abutments. 0. 1. 2 mm height
• . P64-3.75 standard platform, straight adaptor abutment, 1, 2, 3, 4, 5 mm heights
• P64 plastic and Ti alloy sleeve
• P64 healing cap ●
• PK standard platform, anatomic anti-rotation abutment, 1, 2, 3, 4 mm height
• PK plastic sleeve
• . PK healing cap

AI/ML Overview

This document is a 510(k) premarket notification for the A.B. Dental Devices® Dental Implants System. It describes the device, its indications for use, and a comparison to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets those criteria in a typical medical device AI context.

The "Performance Data" section lists several types of engineering analysis and biocompatibility/sterilization/fatigue testing, but these are for the physical dental implant system itself, not for an AI/algorithm-based diagnostic or assistive device. There is no mention of a "device performance" in terms of clinical metrics like sensitivity, specificity, accuracy, or an effect size for human readers.

Therefore, for the specific questions asked about acceptance criteria and a study proving device performance (especially questions related to AI/algorithm performance), the provided text does not contain the requested information.

Here's why and what's missing:

1. A table of acceptance criteria and the reported device performance: Not present. The document focuses on comparing the new components (healing caps, abutments) to previously cleared predicate devices based on material, diameter, platform, length, design, and sterility. There are no performance metrics or acceptance criteria for a diagnostic/assistive function.

2. Sample size used for the test set and the data provenance: Not applicable as there is no "test set" for an AI algorithm. The performance data mentioned relates to physical testing (e.g., fatigue testing), but not clinical trials or data for an algorithm.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no ground truth established for an AI algorithm.

4. Adjudication method 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 document is not for an AI-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI algorithm.

7. The type of ground truth used: Not applicable.

8. The sample size for the training set: Not applicable.

9. How the ground truth for the training set was established: Not applicable.

In summary, this document is a 510(k) submission for conventional dental implant components, not an AI-powered medical device. As such, it does not contain the information requested about acceptance criteria and studies proving the performance of an AI/algorithm-based device.

Regulation Number and Section

§ 872.3630 Endosseous dental implant abutment.

(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)