Data / Medical devices / South Korea / Dentium Co., Ltd.
Dentium Co., Ltd.: FDA-registered device maker in Suwon-si Gyeonggi, South Korea, 16 510(k) clearances
Dentium Co., Ltd. is registered with the FDA (registration 3004578807) in Suwon-si Gyeonggi, South Korea. It lists 7 device types. The FDA files 16 510(k) clearances under its listings, the newest dated February 23, 2022. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3004578807
- Address
- 76, Changnyong-daero 256beon-gil, Yeongtong-gu, Suwon-si Gyeonggi, South Korea, 16229
- Owner or operator
- Dentium USA (9063757)
- Roles
- Manufacturer
- First device listed
- November 1, 2004
- Registered through
- 2027
- Brand names listed
- AAB154515H, AAB154515HE, AAB154515HL, AAB154515HT, AAB154515N, AAB154515NE, AAB154515NG, AAB154515NL 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 |
| Chisel, Osteotome, Surgical | EMM | 1 | Manufacturer | accessdata.fda.gov |
| Crown, Preformed | ELZ | 1 | Manufacturer | accessdata.fda.gov |
| Driver, Band, Orthodontic | ECT | 1 | Manufacturer | accessdata.fda.gov |
| Gauge, Depth, Instrument, Dental | EIL | 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 |
|---|---|---|---|---|---|---|
| February 23, 2022 | K213599 | SuperLine | DZE | Substantially Equivalent | Dentium Co., Ltd. | accessdata.fda.gov |
| January 23, 2020 | K192436 | Healing Abutments and Cover Screws | NHA | Substantially Equivalent | Dentium Co., Ltd. | accessdata.fda.gov |
| November 4, 2019 | K191634 | Scan Abutments and Comfort Caps | NHA | Substantially Equivalent | Dentium Co., Ltd. | accessdata.fda.gov |
| May 14, 2018 | K172640 | Dentium Implantium & SuperLine Prosthetics | NHA | Substantially Equivalent | Dentium Co., Ltd. | accessdata.fda.gov |
| January 11, 2018 | K171622 | Dentium Ti-Base | NHA | Substantially Equivalent | Dentium Co., Ltd. | accessdata.fda.gov |
| August 17, 2017 | K170384 | Dentium NR Line CAD/CAM Abutments | NHA | Substantially Equivalent | Dentium Co., Ltd. | accessdata.fda.gov |
| January 13, 2017 | K160965 | SuperLine | DZE | Substantially Equivalent | Dentium Co., Ltd. | accessdata.fda.gov |
| December 16, 2016 | K161713 | Dentium CAD/CAM Abutments | NHA | Substantially Equivalent | Dentium Co., Ltd. | accessdata.fda.gov |
| September 15, 2016 | K160828 | Dentium Implantium & SuperLine Prosthetics | NHA | Substantially Equivalent | Dentium Co., Ltd. | accessdata.fda.gov |
| August 5, 2016 | K160483 | Burn-out Cylinder and Angled Screw Abutments | NHA | Substantially Equivalent | Dentium Co., Ltd. | accessdata.fda.gov |
| July 20, 2016 | K153268 | NR Line Implant System | DZE | Substantially Equivalent | Dentium Co., Ltd. | accessdata.fda.gov |
| November 12, 2014 | K141457 | DENTIUM IMPLANTIUM AND SUPERLINE ABUTMENTS | NHA | Substantially Equivalent | Dentium Co., Ltd. | accessdata.fda.gov |
| January 26, 2012 | K112045 | SIMPLELINE II ABUTMENT SYSTEM | NHA | Substantially Equivalent | Dentium Co., Ltd. | accessdata.fda.gov |
| November 22, 2010 | K102308 | SIMPLELINE II MODEL SOFX483408R, SOFX483410R TOTAL 44 MODELS | DZE | Substantially Equivalent | Dentium Co., Ltd. | accessdata.fda.gov |
| July 27, 2006 | K052957 | IMPLANTIUM PROSTHETICS | NHA | Substantially Equivalent | Dentium Co., Ltd. | accessdata.fda.gov |
| July 29, 2004 | K041368 | DENTIUM CO., LTD. IMPLANTIUM | DZE | Substantially Equivalent | Dentium Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Implant, Endosseous, Root-Form
- All makers of Abutment, Implant, Dental, Endosseous
- All makers of Gauge, Depth, Instrument, Dental
- All makers of Driver, Band, Orthodontic
- All makers of Crown, Preformed
- All makers of Chisel, Osteotome, Surgical
Updated February 23, 2022. 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.