# K170732: Biomate Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Biomate Medical Devices Technology Co., Ltd.
- Decided: Oct 26, 2018 after 595 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: 10 generations back to K960026 (1996). 67 ancestors in all.
No later device cites it as a predicate yet.
0 of 68 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142174: Biomate Dental Implant System, Biomate Medical Devices Technology Co., Ltd. (2015) Summary page 5.

## Indications for use
An endosseous dental implant is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple unit prosthetic appliance attachment to restore a patient's chewing function. Implants can be placed with a conventional 2 stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading. It is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Patients must be subject for dental treatment with endosseous implants.

Source page: https://510kreport.com/device/K170732
Methodology: https://510kreport.com/methodology