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Z7, LLC

FDA Regulatory Profile

Z7, LLC has 0 FDA recalls, 1 inspection, 1 510(k) clearance and 0 compliance actions on record.

Latest inspection
Jan 21, 2025 · VAI
Latest 510(k)
Jun 26, 2023

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances1Oct 4, 2026Not statedCurrent
Inspections1Oct 26, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Jan 21, 2025Whitehouse Station, NJDevicesVoluntary Action Indicated (VAI)3024852742

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

Recent 510(k) Clearances

K-NumberDeviceDate
K221488Z7 Zirconia Implant SystemJun 26, 2023

FDA data resources