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

Name: FDA 510(k) clearance K880982
Creator: U.S. Food and Drug Administration
Published: 1988-06-06

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. Device class: 2.

Clearance details

Applicant: Orion Corporation Soredex
Product code: Code KPR
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 1988-03-08
Decision date: 1988-06-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Helsinki, FI

Download summary PDF View on FDA.gov ↗

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K934949 — DIGORA1994-02-10

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.