Ruthinium Disc

FDA 510(k) K261456 · Dental Manufacturing S.p.A.

Substantially Equivalent

510(k) numberK261456

Submission

Device name
Ruthinium Disc
Applicant
Dental Manufacturing S.p.A.
Badia Polesine, IT
Received
May 1, 2026
Decision date
August 5, 2026
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
POW – Crown And Bridge, Long-Term Temporary, Resin
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3770
Specialty
Dental

For the fabrication of long-term temporary crowns and bridges

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K231591V-Print c&b tempPOW · Traditional Voco GmbH07/31/2023SE

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Questions and answers

When was Ruthinium Disc cleared by the FDA?

Ruthinium Disc (K261456) received a 510(k) decision of Substantially Equivalent on August 5, 2026, 96 days after the submission was received.

What is the product code of K261456?

The FDA product code is POW – Crown And Bridge, Long-Term Temporary, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3770.