DUAL INTEGRATOR DENTAL IMPLANT ACCESSORIES PARALLEL PIN, DEPTH GAGE, AND SURGICAL RATCHET— 510(k) K970572

Substantially Equivalent

Implant Integration Systems, Inc.

FDA 510(k) clearance K970572 for DUAL INTEGRATOR DENTAL IMPLANT ACCESSORIES PARALLEL PIN, DEPTH GAGE, AND SURGICAL RATCHET, Substantially Equivalent on 1998-01-16. Applicant: Implant Integration Systems, Inc..

Clearance details

Applicant: Implant Integration Systems, Inc.
Product code: Code DZE
Advisory panel: Dental
Date received: 1997-02-14
Decision date: 1998-01-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Paradise, CA, US

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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.