Data / Medical devices / United States / Elegant Direct Corp
Elegant Direct Corp: FDA-registered device maker in Brooklyn, NY, United States, 1 510(k) clearance
Elegant Direct Corp is registered with the FDA (registration 3013465593) in Brooklyn, NY, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 22, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013465593
- Address
- 2308 McDonald Ave, Brooklyn, NY, United States, 11223
- Owner or operator
- ELEGANT DIRECT CORP (10076895)
- Roles
- Manufacturer
- First device listed
- August 4, 2020
- Registered through
- 2026
- Brand names listed
- DURANEXT
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 |
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 22, 2020 | K200355 | Duranext Abutments | NHA | Substantially Equivalent | Elegant Dental Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Abutment, Implant, Dental, Endosseous
- All makers of Accessories, Implant, Dental, Endosseous
Updated July 22, 2020. 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.