Manufacturer registered with FDA

Z7 LLC

Whitehouse Station, NJ, United States. Lists 2 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.

FDA owner/operator10088405Specification developer1 clearance in five years

Device types listed: 2
Brands and models: 2
510(k) clearances: 12023–2023
Markets registered in: 1United States
Establishments: 1United States

510(k) clearances per year, 2007–2026

Devices listed with FDA

What Z7 LLC currently lists, by FDA device type, with the brand and model names on the listing.

Device type	Category	Role	Brands and models	Listed since
Root-Form Endosseous ImplantDZE · Class 2	Dental implants	Maker	ZiNova Implants	2023
Endosseous Dental Implant AbutmentNHA · Class 2	Implant abutments	Maker	ZiNova Implants	2023

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

510(k) clearances

Clearances on which FDA names Z7 LLC as the applicant.

Decided	510(k)	Device	Device type
26 Jun 2023	K221488	Z7 Zirconia Implant System	DZE Root-Form Endosseous Implant

Registered establishments

Establishment	Location	What it does
Z7 LLCFDA reg. 3024852742	Whitehouse Station, NJ, United States	Complaint file establishment, Specification developer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10088405). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.