CODIAGNOSTIX IMPLANT PLANNING SOFTWARE— 510(k) K130724

Substantially Equivalent

Straumann USA

FDA 510(k) clearance K130724 for CODIAGNOSTIX IMPLANT PLANNING SOFTWARE, Substantially Equivalent on 2013-06-28. Applicant: Straumann USA.

Clearance details

Applicant: Straumann USA
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2013-03-18
Decision date: 2013-06-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Andover, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

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.