Data / Medical devices / South Korea / Dentos, Incorporated
Dentos, Incorporated: FDA-registered device maker in Daegu, South Korea, 2 510(k) clearances
Dentos, Incorporated is registered with the FDA (registration 3006034256) in Daegu, South Korea. It lists 11 device types. The FDA files 2 510(k) clearances under its listings, the newest dated February 5, 2019. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3006034256
- Address
- 41 Seongseo-ro 68-gil, Dalseo-gu, Daegu, South Korea, 42697
- Owner or operator
- DENTOS, INCORPORATED (9081942)
- Roles
- Manufacturer
- First device listed
- August 24, 2006
- Registered through
- 2027
- Brand names listed
- 3PP (3 Prong plier), 3PPM (Mini 3 Prong plier), AA-18-11, AA-18-12, AA-18-13H, AA-18-16H, AA-18-17H, AA-18-21 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Band, Elastic, Orthodontic | ECI | 1 | Manufacturer | accessdata.fda.gov |
| Bit, Drill | HTW | 1 | Manufacturer | accessdata.fda.gov |
| Bracket, Metal, Orthodontic | EJF | 1 | Manufacturer | accessdata.fda.gov |
| Clamp, Wire, Orthodontic | ECN | 1 | Manufacturer | accessdata.fda.gov |
| Driver, Band, Orthodontic | ECT | 1 | Manufacturer | accessdata.fda.gov |
| Implant, Endosseous, Orthodontic | OAT | 2 | Manufacturer | accessdata.fda.gov |
| Implant, Endosseous, Root-Form | DZE | 2 | Manufacturer | accessdata.fda.gov |
| Plier, Orthodontic | JEX | 1 | Manufacturer | accessdata.fda.gov |
| Spring, Orthodontic | ECO | 1 | Manufacturer | accessdata.fda.gov |
| Wax, Dental, Intraoral | EGD | 1 | Manufacturer | accessdata.fda.gov |
| Wire, Orthodontic | DZC | 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 |
|---|---|---|---|---|---|---|
| February 5, 2019 | K181142 | Absoanchor Microimplant | OAT | Substantially Equivalent | Dentos, Inc. | accessdata.fda.gov |
| May 16, 2006 | K060126 | ABSOANCHOR MICROIMPLANT | DZE | Substantially Equivalent | Dentos, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Wire, Orthodontic
- All makers of Plier, Orthodontic
- All makers of Implant, Endosseous, Root-Form
- All makers of Clamp, Wire, Orthodontic
- All makers of Wax, Dental, Intraoral
- All makers of Implant, Endosseous, Orthodontic
Updated February 5, 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.