BIORES Dental Implant System— 510(k) K252286

Name: FDA 510(k) clearance K252286
Creator: U.S. Food and Drug Administration
Published: 2026-02-02

Substantially Equivalent

Chengdu Besmile Medical Technology Co., Ltd.

FDA 510(k) clearance K252286 for BIORES Dental Implant System, Substantially Equivalent on 2026-02-02. Applicant: Chengdu Besmile Medical Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Chengdu Besmile Medical Technology Co., Ltd.
Product code: Code DZE
Device class: Class 2
Regulation: 21 CFR 872.3640
Advisory panel: Dental
Date received: 2025-07-23
Decision date: 2026-02-02
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Chengdu, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code DZE

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K260463 — ZEROS Dental Implant System2026-08-19
K251188 — UNIQA® Dental Implants System2026-06-25
K250806 — Dental Implant System2026-06-18
K251232 — MegaGen Zygoma Dental Implant System2026-06-18
K260006 — INOSS System2026-06-17

More clearances from Chengdu Besmile Medical Technology Co., Ltd.

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K242768 — Customized Abutment and Screw2025-09-02
K232682 — Pre-Sintered Zirconia Coloring Liquid2024-03-19
K232673 — Dental Glass Ceramics2024-01-23
K232676 — Dental Porcelain Powder2024-01-23

Adverse events under product code DZE

product code DZE

Death: 28
Injury: 3,367,041
Malfunction: 19,958
Other: 13
Total: 3,387,040

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.