BIORES Dental Implant System— 510(k) K252286
Substantially EquivalentChengdu 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.
Summary
Chengdu Besmile Medical Technology's BIORES Dental Implant System is filed under product code DZE (Implant, Endosseous, Root-Form). The record doesn't describe the system beyond its name and that code name.
Class II, 21 CFR 872.3640. Dental is both the classification panel and the review panel. It came in as an Abbreviated 510(k).
Chengdu Besmile Medical Technology filed from Chengdu, China. Review took 194 calendar days (July 23, 2025 to February 2, 2026), ending in a substantially equivalent decision.
Clearance details
- Applicant
- Chengdu Besmile Medical Technology Co., Ltd.
- Product code
- Product code DZE
- Device class
- Class 2
- Regulation
- 21 CFR 872.3640
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Chengdu, CN
Recent devices under product code DZE
view allMore clearances from Chengdu Besmile Medical Technology Co., Ltd.
view allAdverse 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, through . 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.