BICON IMPLANTS WITH A 2.5MM INTERNAL CONNECTION— 510(k) K092035

Substantially Equivalent

Bicon, LLC

FDA 510(k) clearance K092035 for BICON IMPLANTS WITH A 2.5MM INTERNAL CONNECTION, Substantially Equivalent on 2009-10-15. Applicant: Bicon, LLC.

Clearance details

Applicant: Bicon, LLC
Product code: Code DZE
Advisory panel: Dental
Date received: 2009-07-06
Decision date: 2009-10-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boston, MA, US

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.