# K210499: Alpha Dent Implants Dental Implants System

- Pathway: 510(k) (Traditional)
- Applicant: Alpha Dent Implants GmbH
- Decided: Nov 1, 2021 after 252 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
Longest line of descent: 11 generations back to K894595 (1990). 27 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181138: IS-III active System, Neobiotech Co., Ltd. (2018) Summary page 4.

## Most influential descendants
- K240435: Alpha Dent Implants Dental Implants System (2024), 0 descendants of its own

## Indications for use
Alpha Dent Implants Dental Implants System is intended for surgical placement in the maxillary and/or the mandibular arch, to support crowns, bridges, or over dentures, in edentulous patients. It is intended to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function. The System is intended to be used in either single tooth or multiple teeth applications. The prostheses can be screw or cement retained to the abutment. The Alpha Dent Implants 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/K210499
Methodology: https://510kreport.com/methodology