Ruthinium Disc— 510(k) K261456
Substantially EquivalentDental 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.
Summary
Dental Manufacturing's Ruthinium Disc is filed under product code POW, long-term temporary resin crown and bridge. The record gives no sizes or shades.
Class II, 21 CFR 872.3770. Dental is both the classification panel and the review panel. It came in as a Traditional 510(k).
Dental Manufacturing filed from Badia Polesine, Italy. The substantially equivalent decision came 96 calendar days after receipt (May 1 to August 5, 2026).
Clearance details
- Applicant
- Dental Manufacturing S.p.A.
- Product code
- Product code POW
- Device class
- Class 2
- Regulation
- 21 CFR 872.3770
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Badia Polesine, IT
Recent devices under product code POW
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