ZTI IMPLANTS SYSTEM, DRM IMPLANTS— 510(k) K034067

Name: FDA 510(k) clearance K034067
Creator: U.S. Food and Drug Administration
Published: 2004-03-08

Substantially Equivalent

Drm Research Laboratories, Inc.

FDA 510(k) clearance K034067 for ZTI IMPLANTS SYSTEM, DRM IMPLANTS, Substantially Equivalent on 2004-03-08. Applicant: Drm Research Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Drm Research Laboratories, Inc.
Product code: Code DZE
Device class: Class 2
Regulation: 21 CFR 872.3640
Advisory panel: Dental
Date received: 2003-12-31
Decision date: 2004-03-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Branford, CT, US

Download summary PDF View on FDA.gov ↗

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K260006 — INOSS System2026-06-17

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.