SIDEXIS 4— 510(k) K132773

Substantially Equivalent

Sirona Dental Systems GmbH

FDA 510(k) clearance K132773 for SIDEXIS 4, Substantially Equivalent on 2013-12-11. Applicant: Sirona Dental Systems GmbH.

Clearance details

Applicant: Sirona Dental Systems GmbH
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2013-09-05
Decision date: 2013-12-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bensheim, DE

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.