# K160221: Implance Dental Implant System, Implance Dental Abutment System

- Pathway: 510(k) (Traditional)
- Applicant: Ags Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti.
- Decided: Sep 12, 2016 after 227 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: 9 generations back to K944964 (1995). 141 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 145 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073486: Dentis Dental Implant System, Dentis Co., Ltd. (2008) Summary page 4.
- K122988: Klockner Dental Implant Abutments, Soadco, S.L. (2013) Summary page 4.

## Most influential descendants
- K181266: Implantswiss Dental Implant System, Implantswiss Dental Abutment System (2018), 1 descendant of its own
- K200867: Implantswiss Dental Implant System and Implantswiss Dental Abutment System (2020), 0 descendants of its own
- K163640: QZA and RS Dental Implant Systems (2017), 0 descendants of its own

## Indications for use
Implance Dental Implant System is indicated to use for surgical placement in the upper and lower jaw arches, to provide a root form means for single and multiple units’ prosthetic appliance attachment to restore a patient’s chewing function. Implance Dental Implant can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading. Immediate loading is restricted to the anterior mandible based on four splinted-interforminal placed implants. Implance Dental Abutment System is used with a dental implant to provide support to prosthetic restorations such as crown, bridge and overdentures in partially or fully edentulous patients. Octa Abutment models that contain an abutment post height less than 4 mm are indicated only for multi-unit loading, such as a bridge or overdenture.

Source page: https://510kreport.com/device/K160221
Methodology: https://510kreport.com/methodology