# K252286: BIORES Dental Implant System

- Pathway: 510(k) (Abbreviated)
- Applicant: Chengdu Besmile Medical Technology Co., Ltd.
- Decided: Feb 2, 2026 after 194 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: 14 generations back to K894595 (1990). 115 ancestors in all.
No later device cites it as a predicate yet.
0 of 116 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171027: Dentis Dental Implant System, Dentis Co., Ltd. (2017) Summary page 5.

## Indications for use
BIORES Dental Implant System is an endosseous dental implant that is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple-units prosthetic appliance attachment to restore a patient’s chewing function. Implants 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 when good primary stability has been achieved and with appropriate occlusal loading. Implants with a diameter of 3.7 mm are only suitable for anterior tooth restoration.

Source page: https://510kreport.com/device/K252286
Methodology: https://510kreport.com/methodology