Z7 LLCJanuary 21, 2025

FDA 483 - Z7 LLC - January 21, 2025

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Record Details

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.

Company: Z7 LLC
Inspection Date: January 21, 2025
Product Type: Device
Office: New Jersey District Office
Person: Monica L. Gutierrez

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ID · 1614eb6c-fa4b-484c-a924-e6801553da6e