BRANEMARK INTEGRATION DENTAL IMPLANT AND ACCESSORIES— 510(k) K040643

Substantially Equivalent

Branemark Integration AB

FDA 510(k) clearance K040643 for BRANEMARK INTEGRATION DENTAL IMPLANT AND ACCESSORIES, Substantially Equivalent on 2004-04-07. Applicant: Branemark Integration AB.

Clearance details

Applicant: Branemark Integration AB
Product code: Code DZE
Advisory panel: Dental
Date received: 2004-03-11
Decision date: 2004-04-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Goteborg, SE

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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.