Data / Medical devices / South Korea / ARUM DENTISTRY Co., Ltd.
ARUM DENTISTRY Co., Ltd.: FDA-registered device maker in Yuseong-gu Daejeon, South Korea, 18 510(k) clearances
ARUM DENTISTRY Co., Ltd. is registered with the FDA (registration 3015978392) in Yuseong-gu Daejeon, South Korea. It lists 7 device types. The FDA files 18 510(k) clearances under its listings, the newest dated July 23, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3015978392
- Address
- 23, Gukjegwahak 11-ro, Yuseong-gu Daejeon, South Korea, 34002
- Owner or operator
- ARUM DENTISTRY Co., Ltd (10066396)
- Roles
- Manufacturer
- First device listed
- April 1, 2020
- Registered through
- 2027
- Brand names listed
- ARENA Star, Abutment Remover Tool, Abutment Screw, Anchor Drill, Anchor Screw, Anchor Screw Driver Machine, Angled Abutment, Angled Abutment Mini 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 |
| Crown And Bridge, Temporary, Resin | EBG | 2 | Manufacturer | accessdata.fda.gov |
| Drill, Dental, Intraoral | DZA | 1 | Manufacturer | accessdata.fda.gov |
| Implant, Endosseous, Root-Form | DZE | 2 | Manufacturer | accessdata.fda.gov |
| Material, Tooth Shade, Resin | EBF | 2 | Manufacturer | accessdata.fda.gov |
| Powder, Porcelain | EIH | 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 |
|---|---|---|---|---|---|---|
| July 23, 2025 | K250280 | SD TL Implant System | DZE | Substantially Equivalent | Arum Dentistry Co., Ltd. | accessdata.fda.gov |
| July 10, 2025 | K250063 | ARENA Star, Galaxy Star | EIH | Substantially Equivalent | Arum Dentistry Co., Ltd. | accessdata.fda.gov |
| February 24, 2025 | K241703 | SD Implant System | DZE | Substantially Equivalent | Arum Dentistry Co., Ltd. | accessdata.fda.gov |
| January 6, 2025 | K242753 | SD TL Implant System | DZE | Substantially Equivalent | Arum Dentistry Co., Ltd. | accessdata.fda.gov |
| November 25, 2024 | K242245 | Customized Abutment | NHA | Substantially Equivalent | Arum Dentistry Co., Ltd. | accessdata.fda.gov |
| September 11, 2024 | K232559 | C&B NFH Hybrid | EBF | Substantially Equivalent | Arum Dentistry Co., Ltd. | accessdata.fda.gov |
| June 5, 2024 | K240603 | Ti-Base & Master Fix | NHA | Substantially Equivalent | Arum Dentistry Co., Ltd. | accessdata.fda.gov |
| May 9, 2024 | K234112 | Customized Abutment | NHA | Substantially Equivalent | Arum Dentistry Co., Ltd. | accessdata.fda.gov |
| April 26, 2024 | K240091 | NB Mini Implant System | DZE | Substantially Equivalent | Arum Dentistry Co., Ltd. | accessdata.fda.gov |
| December 19, 2023 | K232560 | Angled Abutment | NHA | Substantially Equivalent | Arum Dentistry Co., Ltd. | accessdata.fda.gov |
| July 1, 2023 | K230725 | NB Implant System | DZE | Substantially Equivalent | Arum Dentistry Co., Ltd. | accessdata.fda.gov |
| April 28, 2023 | K223634 | Customized Abutment | NHA | Substantially Equivalent | Arum Dentistry Co., Ltd. | accessdata.fda.gov |
| February 27, 2023 | K223253 | Non-Sterile Zirconia Block (ARENA Star, Mont Blanc) | EIH | Substantially Equivalent | Arum Dentistry Co., Ltd. | accessdata.fda.gov |
| September 19, 2022 | K222131 | NB 1 SA Implant System | DZE | Substantially Equivalent | Arum Dentistry Co., Ltd. | accessdata.fda.gov |
| April 6, 2022 | K213506 | NB 1 SA Implant System | DZE | Substantially Equivalent | Arum Dentistry Co., Ltd. | accessdata.fda.gov |
| December 8, 2021 | K210817 | C&B 5.0 Hybrid | EBG | Substantially Equivalent | Arum Dentistry Co., Ltd. | accessdata.fda.gov |
| March 9, 2020 | K193425 | Pre-Milled Blank | NHA | Substantially Equivalent | Arum Dentistry Co., Ltd. | accessdata.fda.gov |
| December 20, 2019 | K190112 | Non-Sterile Zirconia Block | EIH | Substantially Equivalent | Fine Advanced Compound Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Abutment, Implant, Dental, Endosseous
- All makers of Implant, Endosseous, Root-Form
- All makers of Accessories, Implant, Dental, Endosseous
- All makers of Powder, Porcelain
- All makers of Drill, Dental, Intraoral
- All makers of Material, Tooth Shade, Resin
Updated July 23, 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.