BONE BLOCK FIXATION SET— 510(k) K050515

Substantially Equivalent

Straumann USA, Inc.

FDA 510(k) clearance K050515 for BONE BLOCK FIXATION SET, Substantially Equivalent on 2005-04-05. Applicant: Straumann USA, Inc..

Clearance details

Applicant: Straumann USA, Inc.
Product code: Code DZL
Advisory panel: Dental
Date received: 2005-03-01
Decision date: 2005-04-05
Decision: Substantially Equivalent
Clearance type: Special
Location: Waltham, MA, 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.