Data / Medical devices / United States / Z7 LLC
Z7 LLC: FDA-registered device maker in Whitehouse Station, NJ, United States, 1 510(k) clearance
Z7 LLC is registered with the FDA (registration 3024852742) in Whitehouse Station, NJ, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 26, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3024852742
- Address
- 28 Felmley Road, Whitehouse Station, NJ, United States, 08889
- Owner or operator
- Z7 LLC (10088405)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- July 15, 2023
- Registered through
- 2026
- Brand names listed
- ZiNova Implants
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Implant, Endosseous, Root-Form | DZE | 2 | Complaint file establishment, Specification developer | 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 |
|---|---|---|---|---|---|---|
| June 26, 2023 | K221488 | Z7 Zirconia Implant System | DZE | Substantially Equivalent | Z7, LLC | accessdata.fda.gov |
Compare with other makers
Updated June 26, 2023. 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.