# K231100: Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech Abutment Screw

- Pathway: 510(k) (Traditional)
- Applicant: Proimtech Saglik Urunleri Anonim Sirketi
- Decided: Aug 23, 2024 after 493 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: 16 generations back to K960026 (1996). 300 ancestors in all.
No later device cites it as a predicate yet.
0 of 301 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140878: Straumann Bone Level Tapered Implant, Straumann USA, LLC (2014) Summary page 6.
- K173961: Straumann BLX Implant System, Institut Straumann AG (2018) Summary page 6.
- K212533: BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants, Institut Straumann AG (2022) Summary page 6.
- K130222: Straumann Dental Implant System, Straumann USA, LLC (2013) Summary page 6.
- K160850: Nucleoss Tpure Implant System, Sanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti (2017) Summary page 6.
- K182448: AnyRidge Octa 1 Implant System, Megagen Implant Co., Ltd. (2019) Summary page 6.
- K052957: Implantium Prosthetics, Dentium Co., Ltd. (2006) Summary page 6.
- K051636: Camlog Dental Implant Abutments, Healing Caps, and Accessories, Altatec GmbH (2006) Summary page 6.

## Indications for use
Indications for use Bilimplant® dental implants are indicated for the functional and esthetic oral rehabilitation of the upper or lower jaw of edentulous or partially edentulous patients. They can be used for immediate, early or late implantation following the extraction or loss of natural teeth. The implants can be placed with immediate function for single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading to restore chewing function. Bilimplant Abutments and Prosthetic parts are intended for use with Bilimplant Dental Implants in the maxillary and / or mandibular arches to provide support for crowns or bridges for edentulous or partially edentulous patients.

Source page: https://510kreport.com/device/K231100
Methodology: https://510kreport.com/methodology