# K183044: JTK Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Jiangyin Jintech Biotech Co., Ltd.
- Decided: Nov 10, 2020 after 739 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: 15 generations back to K960026 (1996). 206 ancestors in all.
No later device cites it as a predicate yet.
0 of 207 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143326: T.A.G. Dental Implant System, T.A.G. Medical Products Corporation, Ltd. (2015) Summary page 5.
- K090234: Spectra System Dental Implants 2008, Implant Direct, LLC (2009) Summary page 5.

## Indications for use
JTK One-Piece Integrated Implant System: The JTK one-piece integrated dental implant system is intended to replace single or multiple teeth in the fully or partially edentulous mandibular or maxillary alveolar process. The implants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading. JTK Two-Piece Implant System: The JTK two-piece dental implant system is comprised of dental implant fixtures and prosthetic devices that compose a two-piece implant system. The implants are intended for use in the mandible and maxilla, in support of single unit or multiple unit cement or screw-receiving restorations and for the retention and support of overdentures. The implants are intended for immediate placement and function for the support of single tooth or multiple-tooth restorations, recognizing bone stability and appropriate occlusal load requirements.

Source page: https://510kreport.com/device/K183044
Methodology: https://510kreport.com/methodology