Z-LOOK3 DENTAL IMPLANT SYSTEM, MODEL Z3-XXX— 510(k) K062542

Substantially Equivalent

Z-Systems AG

FDA 510(k) clearance K062542 for Z-LOOK3 DENTAL IMPLANT SYSTEM, MODEL Z3-XXX, Substantially Equivalent on 2007-10-29. Applicant: Z-Systems AG. Device class: 2.

Clearance details

Applicant: Z-Systems AG
Product code: Code DZE
Device class: Class 2
Regulation: 21 CFR 872.3640
Advisory panel: Dental
Date received: 2006-08-30
Decision date: 2007-10-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DZE

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K260006 — INOSS System2026-06-17

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Adverse events under product code DZE

product code DZE

Death: 28
Injury: 3,367,041
Malfunction: 19,958
Other: 13
Total: 3,387,040

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.