Manufacturer registered with FDA
DMETEC Co., LTD
Bucheon, South Korea. Lists 4 dental device types with FDA across 1 registered establishment, and holds 5 510(k) clearances as applicant.
- Device types listed
- 4
- Brands and models
- 6
- 510(k) clearances
- 52005–2017
- Markets registered in
- 615 registrations outside the US
- Establishments
- 1South Korea
510(k) clearances per year, 2000–2026
Registered in 6 markets
Where regulators' registries name DMETEC 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 | DMETEC Co., LTD | 5 clearances | 2005–2017 | Below |
| Taiwan | TFDA | Manufacturer | DMETEC CO., LTD.DMETEC CO., LTD · DMETEC Co., Ltd. | 7 | 2008–2024 | Pure Global AI |
| Israel | AMAR | Manufacturer | Dmetec Co., LTd. | 4 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Dmetec Co Ltd | 2 | 2018–2022 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | DMETEC CO., LTD. | 1 | 2026–2026 | Pure Global AI |
| China | NMPA | Registration holder | 迪美特 DMETEC 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 DMETEC 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 |
|---|---|---|---|---|
| Powered Bone DrillDZI · Class 2 | Surgical drills & motors | Maker | ULTRASONIC SURGERYULTRASONIC SURGERY MACHINE | 2020 |
| Ultrasonic ScalerELC · Class 2 | Ultrasonic scalers | Maker | CLEANSE S+ ULTRASONIC SCALERCompact S, Compact S(LED) | 2020 |
| Ultraviolet Activator for PolymerizationEBZ · Class 2 | Curing lights | Maker | SKYLIGHT LED CURING LIGHT | 2020 |
| Articulation PaperEFH · Class 1 | — | Maker | ACCURA | 2019 |
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 DMETEC Co., LTD as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 27 Dec 2017 | K170104 | COMPACT S, COMPACT S (LED) | ELC Ultrasonic Scaler |
| 11 Dec 2012 | K121620 | ULTRASONIC SURGERY | DZI Powered Bone Drill |
| 14 Jun 2012 | K113152 | ULTRASONIC SURGERY MACHINE | DZI Powered Bone Drill |
| 29 Mar 2006 | K060171 | CLEANSE S+ ULTRASONIC SCALER | ELC Ultrasonic Scaler |
| 19 Jul 2005 | K051571 | SKYLIGHT LED CURING LIGHT | EBZ Ultraviolet Activator for Polymerization |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| DMETEC CO., LTDFDA reg. 3005344591 | Bucheon Gyeonggi, South Korea | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10062186). 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.