Not currently registered with FDA under this name
Meta Systems Co., Ltd.
Seongnam-Si, South Korea. Named as applicant on 3 dental 510(k) clearances between 2016 and 2025. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 32016–2025
- Markets registered in
- 975 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 2007–2026
Registered in 9 markets
Where regulators' registries name Meta Systems 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 | Applicant | Meta Systems Co., Ltd. | 3 clearances | 2016–2025 | Below |
| European Union | EUDAMED | Manufacturer | META SYSTEMS CO., LTD. | 43 | — | Pure Global AI |
| Canada | Health Canada | Registration holder | META SYSTEMS CO., LTD | 10 | 2020–2022 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | META SYSTEMS CO.,LTDMeta Systems Co., Ltd | 10 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | META SYSTEMS CO., LTD. | 6 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | META SYSTEMS CO., LTD.META Systems Co., Ltd | 2 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | META SYSTEMS CO., LTD. | 2 | 2020–2022 | Pure Global AI |
| China | NMPA | Registration holder | 美塔西斯特医疗器械有限公司META SYSTEMS CO., LTD. | 1 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | MetaSystems GmbH | 1 | 2014–2014 | 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
510(k) clearances
Clearances on which FDA names Meta Systems Co., Ltd. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 14 Oct 2025 | K253461 | Demi Pro | EBZ Ultraviolet Activator for Polymerization |
| 21 Sep 2022 | K210475 | EQ-M | EKX Ac-Powered Direct Drive Handpiece |
| 12 Aug 2016 | K153285 | EMS-200 | EKX Ac-Powered Direct Drive Handpiece |
Some of these clearances are listed with FDA today by another company: Meta Biomed Co, Ltd (2), Sybron Dental Specialties (2).
Sources
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 of the most recent filing, which can be a US agent.