# K111189: Syntec Dental Implant

- Pathway: 510(k) (Traditional)
- Applicant: Syntec Scientific Corp.
- Decided: Dec 20, 2012 after 602 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: 2 generations back to K931767 (1994). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041368: Dentium CO., LTD. Implantium, Dentium Co., Ltd. (2004) Summary page 1.
- K052957: Implantium Prosthetics, Dentium Co., Ltd. (2006) Summary page 1.

## Indications for use
The Syntec Dental Implant is intended to be surgically placed in the bone of the upper or lower jaw arches. To provide support for prosthetic devices, such as to restore the patient's chewing function, and artificial teeth.

Source page: https://510kreport.com/device/K111189
Methodology: https://510kreport.com/methodology