GALILEOS— 510(k) K060892

Substantially Equivalent

Sirona Dental Systems GmbH

FDA 510(k) clearance K060892 for GALILEOS, Substantially Equivalent on 2006-04-14. Applicant: Sirona Dental Systems GmbH. Device class: 2.

Clearance details

Applicant: Sirona Dental Systems GmbH
Product code: Code MUH
Device class: Class 2
Regulation: 21 CFR 872.1800
Advisory panel: Dental
Date received: 2006-04-03
Decision date: 2006-04-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bensheim, DE

Download summary PDF View on FDA.gov ↗

Recent devices under product code MUH

K251793 — SOTA Cloud Smart Sensor (1.5)2026-03-03
K252570 — EzSensor HD, EzSensor UHD2025-11-10
K250687 — Cocoon Solo (DX-7020s)2025-10-24
K251206 — Digital X-Ray DentiMax Pro Imaging System2025-09-24
K240040 — VistaPano S Ceph 2.0 (VistaPano S Ceph) +3 more2024-10-25

More clearances from Sirona Dental Systems GmbH

K160099 — CEREC SpeedGlaze2016-06-02
K151045 — TENEO Dental Treatment Unit and Accessories2015-07-24
K150909 — INTEGO Family and Accesories2015-07-17
K150750 — Endo 6:1, T1 Line Endo 6 L, SIRONiTi Apex, T1 Spray2015-07-02
K150217 — ORTHOPHOS SL2015-05-08

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