# K202144: A.B. Dental Devices Dental Implants System

- Pathway: 510(k) (Traditional)
- Applicant: A.B. Dental Device, Ltd.
- Decided: Sep 23, 2022 after 784 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K181580 (2019). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181580: Cortex CAD/CAM Abutments, Cortex Dental Implants Industries, Ltd. (2019) Summary page 4.

## Indications for use
AB Dental CAD/CAM Base Abutments and Adhesive Sleeves are dental prosthetics placed onto a dental implant or screw retained abutment, to provide support for dental prosthetic restorations. The Base Abutments and Adhesive Sleeves include: Titantum bases/sleeves with a pre-machined implant connection or screw retained abutment connection on which the CAD/CAM designed upper structure may be fitted to complete a two-piece dental abutment. The Base Abutments and Adhesive Sleeves include an abutment/sleeve screw for fixation to the underlying implant/screw retained abutment. These dental prosthetics may be used for single-unit (single-tooth) or multiple-unit (bridges and bars) restorations and are compatible for use with AB Dental Implants with mnternal connection and screw retained connections for standard and narrow platforms. All digitally designed abutments and/or copings for use with AB Dental CAD/CAM Base Abutments and Adhesive Sleeves are intended to be sent to AB Dental validated milling center for manufacture.

Source page: https://510kreport.com/device/K202144
Methodology: https://510kreport.com/methodology