# K250806: Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: A.B. Dental Devices, Ltd.
- Decided: Jun 18, 2026 after 458 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The A.B. Dental Devices dental implant system is indicated for prosthodontic reconstruction in partially or completely edentulous patients. The dental implants are intended for placement in the maxilla or mandible to anchor and support dental prosthetic restorations. Implant placement may be performed using either a one-stage or two-stage surgical protocol. One-piece implants are intended for use only with a one-stage surgical procedure. When a one-stage surgical approach is applied, the implants are intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Narrow (3.0 mm) implants from the I5 and I55 families are intended for single-unit restorations in maxillary or mandibular incisor positions. Short (length <7 mm) implants are intended for use only with straight abutments and should be placed using a two-stage surgical approach only. Prosthetic products are intended for integration with a dental implant to support single or multiple tooth prostheses. All digitally designed abutments for use with AB Dental Pre-Face Blank Abutments are intended to be sent to AB Dental validated milling center for manufacture.

Source page: https://510kreport.com/device/K250806
Methodology: https://510kreport.com/methodology