Manufacturer registered with FDA
Chengdu Besmile Medical Technology Co., Ltd.
Chengdu, China. Lists 6 dental device types with FDA across 1 registered establishment, and holds 5 510(k) clearances as applicant.
- Device types listed
- 6
- Brands and models
- 20
- 510(k) clearances
- 52024–2026
- Markets registered in
- 931 registrations outside the US
- Establishments
- 1China
510(k) clearances per year, 2007–2026
Registered in 9 markets
Where regulators' registries name Chengdu Besmile Medical Technology Co., Ltd. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Chengdu Besmile Medical Technology Co., Ltd. | 5 clearances | 2024–2026 | Below |
| European Union | EUDAMED | Manufacturer | Chengdu Besmile Medical Technology Co., Ltd. | 11 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Chengdu Besmile Medical Technology Co., Ltd. | 9 | — | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Chengdu Besmile Medical Technology Co., LtdChengdu Besmile Medical Technology Co., Ltd. | 3 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Chengdu Besmile Medical Technology Co., Ltd. | 3 | 2025–2025 | Pure Global AI |
| Japan | PMDA | Registration holder | Ｃｈｅｎｇｄｕ Ｂｅｓｍｉｌｅ Ｍｅｄｉｃａｌ Ｔｅｃｈｎｏｌｏｇｙ Ｃｏ．， Ｌｔｄ． | 2 | 2025–2025 | Pure Global AI |
| Australia | TGA | Manufacturer | Chengdu Besmile Medical Technology Co Ltd | 1 | 2025–2025 | Pure Global AI |
| Canada | Health Canada | Registration holder | CHENGDU BESMILE MEDICAL TECHNOLOGY CO., LTD. | 1 | 2026–2026 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Chengdu Besmile Medical Technology Co., Ltd. | 1 | 2020–2020 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Chengdu Besmile Medical Technology Co., Ltd. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Porcelain PowderEIH · Class 2 | Dental ceramics & zirconia | Maker | Dental Glass CeramicsDental Porcelain PowderPre-Sintered Zirconia Coloring LiquidZirconia Dental Ceramics | 2023 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | BIORES Dental Implant SystemCustomized Abutment and Screw | 2025 |
| Intraoral Dental DrillDZA · Class 1 | Surgical drills & motors | Maker | Drill | 2026 |
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | BIORES Dental Implant System | 2026 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | AnalogDepth GaugeDrill ExtensionDrill StopDriverImpression PostParallel PinScanbodyScrew DriverSurgical Guide Resin 1 moreTorque Wrench | 2024 |
| Computer Assisted Design and Manufacturing (Cad/Cam) of Dental Restorations Optical Impression SystemNOF · Class 2 | Intraoral scanners | Maker | Intraoral Scanner | 2025 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Chengdu Besmile Medical Technology Co., Ltd. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 2 Feb 2026 | K252286 | BIORES Dental Implant System | DZE Root-Form Endosseous Implant |
| 2 Sep 2025 | K242768 | Customized Abutment and Screw | NHA Endosseous Dental Implant Abutment |
| 19 Mar 2024 | K232682 | Pre-Sintered Zirconia Coloring Liquid | EIH Porcelain Powder |
| 23 Jan 2024 | K232676 | Dental Porcelain Powder | EIH Porcelain Powder |
| 23 Jan 2024 | K232673 | Dental Glass Ceramics | EIH Porcelain Powder |
Also lists devices cleared under other names
Chengdu Besmile Medical Technology Co., Ltd. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Chengdu Besmile Biotechnology Co., Ltd. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 1 Aug 2017 | K170894 | Zirconia Dental Ceramics | Chengdu Besmile Biotechnology Co., Ltd. | EIH Porcelain Powder |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| CHENGDU BESMILE MEDICAL TECHNOLOGY CO., LTD.FDA reg. 3013102320 | Chengdu Sichuan, China | Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10089441). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.