Data / Medical devices / South Korea / Dentis Co.,Ltd
Dentis Co.,Ltd: FDA-registered device maker in Dong-gu Daegu, South Korea, 1 510(k) clearance
Dentis Co.,Ltd is registered with the FDA (registration 3036190511) in Dong-gu Daegu, South Korea. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated March 4, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3036190511
- Address
- 87, Yuram-ro, Dong-gu Daegu, South Korea, 41059
- Owner or operator
- Dentis Co., Ltd. (10025697)
- Roles
- Manufacturer
- First device listed
- July 14, 2009
- Registered through
- 2027
- Brand names listed
- AXEL AOX KIT (DSAAONK, DSAAOMK), Aqua Tip (DSSAT, DSSAT31, DSSAT41), BMS Chisel (DSCL-05), BONE PROFILER KIT (DBPK), Bone Chip (DGBC50), Bone Profiler (DBP45, DBP55, DBP65), Bone Profiler Base (DBPBM, DBPBR, DBPBN), Bone Ridge Chisel (DBCA15, DBCA25) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| March 4, 2026 | K253493 | Dentis SQ-SL AXEL Fixture | DZE | Substantially Equivalent | Dentis Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated March 4, 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.