FDA.reportPublic FDA data

510(k) K252286

Device
BIORES Dental Implant System
Applicant
Chengdu Besmile Medical Technology Co., Ltd.
510(k) number
K252286
Product code
DZE
Decision
Substantially Equivalent (SESE)
Decision date
2026-02-02
Date received
2025-07-23
Regulation
872.3640
Classification name
Implant, Endosseous, Root-Form
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Abbreviated
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Moushan Liu
Address
#9,Sec.2, Shengwucheng N. Rd. Chengdu Tianfu International Bio-Town, Shuangliu District Chengdu CN 610200 610200

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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