Cleared Abbreviated

BIORES Dental Implant System

K252286 · Chengdu Besmile Medical Technology Co., Ltd. · Dental
Feb 2026
Decision
194d
Days
Class 2
Risk

About This 510(k) Submission

K252286 is an FDA 510(k) clearance for the BIORES Dental Implant System, a Implant, Endosseous, Root-form (Class II — Special Controls, product code DZE), submitted by Chengdu Besmile Medical Technology Co., Ltd. (Chengdu, CN). The FDA issued a Cleared decision on February 2, 2026, 194 days after receiving the submission on July 23, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K252286 FDA.gov
FDA Decision Cleared SESE
Date Received July 23, 2025
Decision Date February 02, 2026
Days to Decision 194 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code DZE — Implant, Endosseous, Root-form
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3640

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