Data / Medical devices / China / Chengdu Besmile Medical Technology Co., Ltd.
Chengdu Besmile Medical Technology Co., Ltd.: FDA-registered device maker in Chengdu Sichuan, China, 6 510(k) clearances
Chengdu Besmile Medical Technology Co., Ltd. is registered with the FDA (registration 3013102320) in Chengdu Sichuan, China. It lists 14 device types. The FDA files 6 510(k) clearances under its listings, the newest dated February 2, 2026. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3013102320
- Address
- No.9,Sec.2, Shengwucheng North Rd., Chengdu Tianfu International Bio-Town, Shuangliu District, Chengdu Sichuan, China, 610200
- Owner or operator
- Chengdu Besmile Medical Technology Co., Ltd. (10089441)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- December 11, 2023
- Registered through
- 2026
- Brand names listed
- ACRYLIC DENTURE, Analog, BIORES Dental Implant System, CAD/CAM Fused resin crown PEEK, CAD/CAM Fused resin pontic PEEK, CAD/CAM Post & core PEEK, CAD/CAM Post & core Resin, CAD/CAM crown PEEK and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Manufacturer | accessdata.fda.gov |
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Manufacturer | accessdata.fda.gov |
| Denture, Cosmetic Only | NXJ | N | Manufacturer | accessdata.fda.gov |
| Dentures, Full | NSL | N | Manufacturer | accessdata.fda.gov |
| Dentures, Partial | NSK | N | Manufacturer | accessdata.fda.gov |
| Drill, Dental, Intraoral | DZA | 1 | Manufacturer | accessdata.fda.gov |
| Implant, Endosseous, Root-Form | DZE | 2 | Manufacturer | accessdata.fda.gov |
| Powder, Porcelain | EIH | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Restoration, Base Metal | NSQ | N | Manufacturer | accessdata.fda.gov |
| Restoration, Porcelain | NSP | N | Manufacturer | accessdata.fda.gov |
| Restoration, Porcelain-Fused-To-Metal | NSO | N | Manufacturer | accessdata.fda.gov |
| Restoration, Resin | NSM | N | Manufacturer | accessdata.fda.gov |
| Restoration, Resin, Crown And Bridge | NSN | N | Manufacturer | accessdata.fda.gov |
| System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | NOF | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 2, 2026 | K252286 | BIORES Dental Implant System | DZE | Substantially Equivalent | Chengdu Besmile Medical Technology Co., Ltd. | accessdata.fda.gov |
| September 2, 2025 | K242768 | Customized Abutment and Screw | NHA | Substantially Equivalent | Chengdu Besmile Medical Technology Co., Ltd. | accessdata.fda.gov |
| March 19, 2024 | K232682 | Pre-Sintered Zirconia Coloring Liquid | EIH | Substantially Equivalent | Chengdu Besmile Medical Technology Co., Ltd. | accessdata.fda.gov |
| January 23, 2024 | K232676 | Dental Porcelain Powder | EIH | Substantially Equivalent | Chengdu Besmile Medical Technology Co., Ltd. | accessdata.fda.gov |
| January 23, 2024 | K232673 | Dental Glass Ceramics | EIH | Substantially Equivalent | Chengdu Besmile Medical Technology Co., Ltd. | accessdata.fda.gov |
| August 1, 2017 | K170894 | Zirconia Dental Ceramics | EIH | Substantially Equivalent | Chengdu Besmile Biotechnology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Drill, Dental, Intraoral
- All makers of Powder, Porcelain
- All makers of Restoration, Porcelain
- All makers of Abutment, Implant, Dental, Endosseous
- All makers of Restoration, Resin, Crown And Bridge
- All makers of Restoration, Base Metal
Updated February 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.