Cleared Traditional

K261456 - Ruthinium Disc

K261456 is an FDA 510(k) clearance for Ruthinium Disc, manufactured by Dental Manufacturing S.P.A. The device is a Class 2 Dental device with product code POW cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K261456 · Dental Manufacturing S.P.A · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2026
Decision
96d
Days
Class 2
Risk

K261456 is an FDA 510(k) clearance for the Ruthinium Disc. Classified as Crown And Bridge, Long-term Temporary, Resin (product code POW), Class II - Special Controls.

Submitted by Dental Manufacturing S.P.A (Badia Polesine, IT). The FDA issued a Cleared decision on August 5, 2026 after a review of 96 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3770 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Dental Manufacturing S.P.A devices

FDA 510(k) Submission Details - K261456

510(k) Number K261456 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2026
Decision Date August 05, 2026
Days to Decision 96 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 127d · This submission: 96d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

POW Device Classification - Class 2, Special Controls

Product Code POW Crown And Bridge, Long-term Temporary, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3770
Definition For The Fabrication Of Long-term Temporary Crowns And Bridges
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Consultant

Ruthinium USA
Celline Souza Lakus

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.