IonoStar Plus— 510(k) K160774

Substantially Equivalent

Voco GmbH

FDA 510(k) clearance K160774 for IonoStar Plus, Substantially Equivalent on 2016-08-03. 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: 2016-03-21
Decision date: 2016-08-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cuxhaven, DE

Download summary PDF View on FDA.gov ↗

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Recalls naming K160774

K-number listed on FDA's recall record

Z-1142-2024 — IonoStar Plus, Catalog (REF) Numbers: a) 2540, b)2543, c) 2544, d) 2545, e) 2546, f) 2547, g) 2549; 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 K160774.

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