# K142557: Anker Dental Implant System - SB-III, ST and AT series

- Pathway: 510(k) (Traditional)
- Applicant: Alliance Global Technology Co., Ltd.
- Decided: Sep 21, 2015 after 375 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: 13 generations back to K894844 (1990). 202 ancestors in all.
No later device cites it as a predicate yet.
0 of 203 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131165: Anker Dental Implant System, Alliance Global (2013) Summary page 4.
- K123784: Straumann Dental Implant System, Straumann USA, LLC (2013) Summary page 4.
- K121585: TS Implant System, Osstem Implant Co., Ltd. (2013) Summary page 4.
- K052957: Implantium Prosthetics, Dentium Co., Ltd. (2006) Summary page 4.
- K130808: Straumann Healing Abutments, Healing Caps, Closure Screws, Straumann USA (2013) Summary page 4.
- K120822: Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann Cares Variobase Abutment WN, ST, Institut Straumann AG (2012) Summary page 4.

## Indications for use
Anker Dental Implant System is intended to be surgically placed in the alveolar bone of upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient’s chewing function. Anker Dental Implant System is intended for delayed loading. No matter placing implants in anterior or posterior region, we recommend choosing the diameter of implants as large as possible. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants through the corresponding components (abutments). Specific indications for small diameter (͟3.3mm) and short (length < 7mm) dental implants: Because of their reduced mechanical stability, small diameter and short implants are only used in cases with a low mechanical load. We recommend only used in the mandibular anterior region and maxillary lateral incisor.

Source page: https://510kreport.com/device/K142557
Methodology: https://510kreport.com/methodology