LEADFIX BIORESORBABLE MEMBRANCE PIN SYSTEM— 510(k) K974392

Substantially Equivalent

Biovision GmbH

FDA 510(k) clearance K974392 for LEADFIX BIORESORBABLE MEMBRANCE PIN SYSTEM, Substantially Equivalent on 1998-01-30. Applicant: Biovision GmbH.

Clearance details

Applicant: Biovision GmbH
Product code: Code DZL
Advisory panel: Dental
Date received: 1997-11-21
Decision date: 1998-01-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, US

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Adverse events under product code DZL

product code DZL

Injury: 168
Total: 168

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.