Data / Medical devices / South Korea / Surgident Co., Ltd.
Surgident Co., Ltd.: FDA-registered device maker in Dong-gu Daegu, South Korea, 2 510(k) clearances
Surgident Co., Ltd. is registered with the FDA (registration 3009551666) in Dong-gu Daegu, South Korea. It lists 9 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 17, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009551666
- Address
- 1F, 2F, 423-7 Hyeoksin-daero, Dong-gu Daegu, South Korea, 41071
- Owner or operator
- Surgident Co., Ltd. (10056549)
- Roles
- Manufacturer
- First device listed
- December 20, 2017
- Registered through
- 2026
- Brand names listed
- 3S SET, AQUA TOCA KIT, BASIC KIT, BONE EXPANDER KIT, BONE MILL, BONE MULTI SYSTEM, BONE SPREADING KIT, C&L SINUS KIT 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 |
| Bur, Dental | EJL | 1 | Manufacturer | accessdata.fda.gov |
| Driver, Band, Orthodontic | ECT | 1 | Manufacturer | accessdata.fda.gov |
| Elevator, Surgical, Dental | EMJ | 1 | Manufacturer | accessdata.fda.gov |
| Instruments, Dental Hand | DZN | 1 | Manufacturer | accessdata.fda.gov |
| Plate, Bone | JEY | 2 | Manufacturer | accessdata.fda.gov |
| Screw, Fixation, Intraosseous | DZL | 2 | Manufacturer | accessdata.fda.gov |
| Unit, Operative Dental, Accessories | NRD | 1 | 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 |
|---|---|---|---|---|---|---|
| May 17, 2019 | K173570 | SD Abutment | NHA | Substantially Equivalent | Surgident Co., Ltd. | accessdata.fda.gov |
| May 24, 2018 | K170697 | GBR system | JEY | Substantially Equivalent | Surgident | accessdata.fda.gov |
Compare with other makers
- All makers of Plate, Bone
- All makers of Screw, Fixation, Intraosseous
- All makers of Abutment, Implant, Dental, Endosseous
- All makers of Driver, Band, Orthodontic
- All makers of Instruments, Dental Hand
- All makers of Accessories, Implant, Dental, Endosseous
Updated May 17, 2019. 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.