IONOLUX— 510(k) K090817

Substantially Equivalent

Voco GmbH

FDA 510(k) clearance K090817 for IONOLUX, Substantially Equivalent on 2009-07-23. Applicant: Voco GmbH. Device class: 2.

Clearance details

Applicant: Voco GmbH
Product code: Code EMA
Device class: Class 2
Regulation: 21 CFR 872.3275
Advisory panel: Dental
Date received: 2009-03-25
Decision date: 2009-07-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cuxhaven, DE

Download summary PDF View on FDA.gov ↗

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Recalls naming K090817

K-number listed on FDA's recall record

Z-1143-2024 — Ionolux, Catalog (REF) Numbers: a) 2115, b)2117, c) 2118, d) 2119, e) 2120, f) 2122; dental cementClass II·Ongoing·Voco GmbH·20240125

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K090817.

Data sourced from openFDA. This site is unofficial and independent of the FDA.