Ruthinium Disc— 510(k) K261456

Substantially Equivalent

Dental Manufacturing S.p.A.

FDA 510(k) clearance K261456 for Ruthinium Disc, Substantially Equivalent on 2026-08-05. Applicant: Dental Manufacturing S.p.A.. Device class: 2.

Clearance details

Applicant: Dental Manufacturing S.p.A.
Product code: Code POW
Device class: Class 2
Regulation: 21 CFR 872.3770
Advisory panel: Dental
Date received: 2026-05-01
Decision date: 2026-08-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Badia Polesine, IT

Download summary PDF View on FDA.gov ↗

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