Planmeca Romexis— 510(k) K171385

Substantially Equivalent

Planmeca Oy

FDA 510(k) clearance K171385 for Planmeca Romexis, Substantially Equivalent on 2017-11-14. Applicant: Planmeca Oy.

Clearance details

Applicant: Planmeca Oy
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2017-05-11
Decision date: 2017-11-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Helsinki, FI

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.