# FDA 483 - Z7 LLC - January 21, 2025

Source: https://www.globalkeysolutions.net/records/483/z7-llc/1614eb6c-fa4b-484c-a924-e6801553da6e

> FDA 483 for Z7 LLC on January 21, 2025. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Z7 LLC
- Inspection Date: 2025-01-21
- Product Type: device
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Z7 LLC, a medical device distributor in Whitehouse Station, NJ, identified a significant compliance issue. The firm failed to submit required information for its ZtNova Implants Systems, sterile dental implants, to the Global Unique Device Identification Database (GUDID). This indicates a lapse in regulatory reporting for medical device identification.

## Related Officers

- [Monica L. Gutierrez](https://www.globalkeysolutions.net/people/monica-l-gutierrez/fe60f8c6-ad1b-4619-9903-ed7be6d3bf7d)

Company: https://www.globalkeysolutions.net/companies/z7-llc/b6356a21-a015-4341-a70d-1312e7c84662

Office: https://www.globalkeysolutions.net/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248