VARIOUS DENTAL IMPLANTS— 510(k) K100411

Substantially Equivalent

Grundy Advanced Biomedical Systems, LLC

FDA 510(k) clearance K100411 for VARIOUS DENTAL IMPLANTS, Substantially Equivalent on 2010-07-28. Applicant: Grundy Advanced Biomedical Systems, LLC.

Clearance details

Applicant: Grundy Advanced Biomedical Systems, LLC
Product code: Code DZE
Advisory panel: Dental
Date received: 2010-02-16
Decision date: 2010-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marion, OH, 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.