# K182455: A.B. DENTAL DEVICES Dental Implants System

- Pathway: 510(k) (Traditional)
- Applicant: A.B. Dental Device, Ltd.
- Decided: Jul 15, 2019 after 311 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: 16 generations back to K960026 (1996). 264 ancestors in all.
No later device cites it as a predicate yet.
0 of 265 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162482: A.B. DENTAL DEVICES Dental Implants System, A.B. Dental Device, Ltd. (2017) Summary page 4.
- K132125: A.B. Dental Devices Dental Implants System, A.B. Dental Devices, Ltd. (2014) Summary page 8.
- K111357: Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant System, Straumann USA (2011) Summary page 4.

## Indications for 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.

Source page: https://510kreport.com/device/K182455
Methodology: https://510kreport.com/methodology