BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants— 510(k) K212533

Substantially Equivalent

Institut Straumann AG

FDA 510(k) clearance K212533 for BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants, Substantially Equivalent on 2022-01-28. Applicant: Institut Straumann AG.

Clearance details

Applicant: Institut Straumann AG
Product code: Code DZE
Advisory panel: Dental
Date received: 2021-08-11
Decision date: 2022-01-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Basel, CH

Download summary PDF View on FDA.gov ↗

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.