Data / Medical devices / South Korea / Simda Co.,ltd.
Simda Co.,ltd.: FDA-registered device maker in Busan, South Korea, 3 510(k) clearances
Simda Co.,ltd. is registered with the FDA (registration 3030426160) in Busan, South Korea. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated December 18, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3030426160
- Address
- 233, Hakgam-daero, Sasang-gu, Busan, Busan, South Korea, 46985
- Owner or operator
- SIMDA CO.,LTD. (10089691)
- Roles
- Manufacturer
- First device listed
- December 28, 2023
- Registered through
- 2026
- Brand names listed
- Lab Analog, SIMDA Abutment, Scan Body
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 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 18, 2025 | K252320 | SIMDA Abutments | NHA | Substantially Equivalent | Simda Co., Ltd. | accessdata.fda.gov |
| October 26, 2023 | K232271 | SIMDA abutment | NHA | Substantially Equivalent | Simda Co., Ltd. | accessdata.fda.gov |
| May 24, 2023 | K223663 | SIMDA Abutment | NHA | Substantially Equivalent | Simda Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated December 18, 2025. 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.