Data / Medical devices / South Korea / DENTALL Co., Ltd.
DENTALL Co., Ltd.: FDA-registered device maker in Bucheon-si Gyeonggi, South Korea, 1 510(k) clearance
DENTALL Co., Ltd. is registered with the FDA (registration 3009307635) in Bucheon-si Gyeonggi, South Korea. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 8, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009307635
- Address
- Bucheontechnopark, 345 Seokcheon-ro, Ojeong-gu, Bucheon-si Gyeonggi, South Korea, 14501
- Owner or operator
- DENTALL Co., Ltd. (10037262)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- June 28, 2011
- Registered through
- 2026
- Brand names listed
- B&Lite S, Camstar, EzCam, LED IC 100, Opti plus HD, ProXam iCam, Somia
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Activator, Ultraviolet, For Polymerization | EBZ | 2 | Manufacturer | accessdata.fda.gov |
| Camera, Surgical And Accessories | KQM | 1 | Contract manufacturer, 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 |
|---|---|---|---|---|---|---|
| August 8, 2017 | K170529 | Delight, Delight ortho, B&Lite S | EBZ | Substantially Equivalent | Dentall Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Activator, Ultraviolet, For Polymerization
- All makers of Camera, Surgical And Accessories
Updated August 8, 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.