Data / Medical devices / South Korea / Dmetec Co., Ltd
Dmetec Co., Ltd: FDA-registered device maker in Bucheon Gyeonggi, South Korea, 5 510(k) clearances
Dmetec Co., Ltd is registered with the FDA (registration 3005344591) in Bucheon Gyeonggi, South Korea. It lists 4 device types. The FDA files 5 510(k) clearances under its listings, the newest dated December 27, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005344591
- Address
- 602,605 Bucheon-Techno-Park 655, Pyeongcheon-ro, Bucheon Gyeonggi, South Korea, 14502
- Owner or operator
- DMETEC Co., LTD (10062186)
- Roles
- Manufacturer
- First device listed
- December 26, 2019
- Registered through
- 2026
- Brand names listed
- ACCURA, CLEANSE S+ ULTRASONIC SCALER, Compact S, Compact S(LED), SKYLIGHT LED CURING LIGHT, ULTRASONIC SURGERY, ULTRASONIC SURGERY MACHINE
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Activator, Ultraviolet, For Polymerization | EBZ | 2 | Manufacturer | accessdata.fda.gov |
| Drill, Bone, Powered | DZI | 2 | Manufacturer | accessdata.fda.gov |
| Paper, Articulation | EFH | 1 | Manufacturer | accessdata.fda.gov |
| Scaler, Ultrasonic | ELC | 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 |
|---|---|---|---|---|---|---|
| December 27, 2017 | K170104 | COMPACT S, COMPACT S (LED) | ELC | Substantially Equivalent | Dmetec.Co., Ltd. | accessdata.fda.gov |
| December 11, 2012 | K121620 | ULTRASONIC SURGERY | DZI | Substantially Equivalent | Dmetec.Co., Ltd. | accessdata.fda.gov |
| June 14, 2012 | K113152 | ULTRASONIC SURGERY MACHINE | DZI | Substantially Equivalent | Dmetec.Co., Ltd. | accessdata.fda.gov |
| March 29, 2006 | K060171 | CLEANSE S+ ULTRASONIC SCALER | ELC | Substantially Equivalent | Dmetec.Co., Ltd. | accessdata.fda.gov |
| July 19, 2005 | K051571 | SKYLIGHT LED CURING LIGHT | EBZ | Substantially Equivalent | Dmetec.Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Drill, Bone, Powered
- All makers of Paper, Articulation
- All makers of Scaler, Ultrasonic
- All makers of Activator, Ultraviolet, For Polymerization
Updated December 27, 2017. 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.