Data / Medical devices / South Korea / Zeros Co., Ltd.
Zeros Co., Ltd.: FDA-registered device maker in Gimhae-si Gyeongnam, South Korea, 3 510(k) clearances
Zeros Co., Ltd. is registered with the FDA (registration 3032439351) in Gimhae-si Gyeongnam, South Korea. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated August 19, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3032439351
- Address
- Building A, 27, Seogimhaesandanan-gil, Gimhae-si Gyeongnam, South Korea, 50967
- Owner or operator
- ZEROS Co., Ltd. (10094653)
- Roles
- Manufacturer
- First device listed
- December 13, 2025
- Registered through
- 2026
- Brand names listed
- Abutment Lab Analog, Ball Driver, Ball Lab Analog, Crest Burr, Drill Extension, Drill Stopper, Esthetic Driver, Esthetic Lab Analog and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Manufacturer | accessdata.fda.gov |
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Manufacturer | accessdata.fda.gov |
| Implant, Endosseous, Root-Form | DZE | 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 |
|---|---|---|---|---|---|---|
| August 19, 2026 | K260463 | ZEROS Dental Implant System | DZE | Substantially Equivalent | Zeros Co., Ltd. | accessdata.fda.gov |
| July 28, 2025 | K241183 | ISO Abutment | NHA | Substantially Equivalent | Seum Medi Co., Ltd. | accessdata.fda.gov |
| March 25, 2024 | K232268 | STERI-OSS Implant System | DZE | Substantially Equivalent | Zeros Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Accessories, Implant, Dental, Endosseous
- All makers of Implant, Endosseous, Root-Form
- All makers of Abutment, Implant, Dental, Endosseous
Updated August 19, 2026. 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.