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FDA 510(k)

Ruthinium Disc

K-Number: K261456 · 2026-08-05

ApplicantDental Manufacturing S.p.A.
Decision Date2026-08-05
Product CodePOW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Ruthinium Disc is the device name listed in this FDA 510(k) record. The listed applicant is Dental Manufacturing S.p.A.. It received FDA 510(k) clearance on 2026-08-05 under 510(k) number K261456. The device is classified under product code POW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ruthinium Disc?

Ruthinium Disc is a medical device that received FDA 510(k) clearance on 2026-08-05. The listed applicant is Dental Manufacturing S.p.A.. The 510(k) number is K261456.

When did Ruthinium Disc receive FDA 510(k) clearance?

Ruthinium Disc received FDA 510(k) clearance on 2026-08-05, under 510(k) number K261456.

Who is the listed applicant for Ruthinium Disc?

The FDA 510(k) record lists Dental Manufacturing S.p.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ruthinium Disc?

The FDA product code for Ruthinium Disc is POW.

Related Devices (Code: POW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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