ORALIX PAN DC III CEPH OR PANORAMIC MODE ONLY— 510(k) K880982

Substantially Equivalent

Orion Corporation Soredex

FDA 510(k) clearance K880982 for ORALIX PAN DC III CEPH OR PANORAMIC MODE ONLY, Substantially Equivalent on 1988-06-06. Applicant: Orion Corporation Soredex.

Clearance details

Applicant: Orion Corporation Soredex
Product code: Code KPR
Advisory panel: Radiology
Date received: 1988-03-08
Decision date: 1988-06-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Helsinki, FI

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Adverse events under product code KPR

product code KPR

Other: 6
Total: 6

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.