Manufacturer registered with FDA
Microware Precision Co., Ltd.
Taichung, Taiwan. Lists 5 dental device types with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.
- Device types listed
- 5
- Brands and models
- 16
- 510(k) clearances
- 22019–2022
- Markets registered in
- 450 registrations outside the US
- Establishments
- 1Taiwan
510(k) clearances per year, 2007–2026
Registered in 4 markets
Where regulators' registries name Microware Precision 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 | Microware Precision Co., Ltd. | 2 clearances | 2019–2022 | Below |
| Colombia | INVIMA | Manufacturer | MICROWARE PRECISION CO., LTDMICROWARE PRECISION CO., LTD. | 41 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | (주)코렌텍^Microware Precision Co., LtdMicroware Precision Co., Ltd · Microware Precision Co., Ltd. · +2 | 8 | 2019–2026 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Microware Precision Co. Ltd. | 1 | — | 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 Microware Precision 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 |
|---|---|---|---|---|
| Bone PlateJEY · Class 2 | Maxillofacial plates & screws | Maker | Biomet Microfixation OmniMax MMF SystemLORENZ 1MM, 1.5MM, 2MM SYSTEMTandry CMF Plate System | 2018 |
| Intraosseous Fixation ScrewDZL · Class 2 | Maxillofacial plates & screws | Maker | Biomet Microfixation OmniMax MMF SystemTandry CMF Plate System | 2018 |
| Orthodontic Endosseous ImplantOAT · Class 2 | — | Maker | BIO-RAY A-1 Anchor Screw SystemOrthodontic Ortholock Screw | 2024 |
| Orthodontic Screw Expansion RetainerDYJ · Class 1 | Retainers, expanders & headgear | Maker | QS Screw | 2026 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Activation KeyDentaBaseDentaBase AbutmentDentaMountHexalobular DriverLance DrillPilot DrillRetaining Abutment Screw | 2026 |
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 Microware Precision Co., Ltd. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 10 Nov 2022 | K220360 | Tandry CMF Plate System | JEY Bone Plate |
| 6 Nov 2019 | K182929 | BIO-RAY A-1 Anchor Screw System | OAT Orthodontic Endosseous Implant |
Some of these clearances are listed with FDA today by another company: Utah Medical Products and Services (1).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| MICROWARE PRECISION CO., LTD.FDA reg. 3007738812 | Taichung, Taiwan | Contract manufacturer, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10028733). 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.