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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Crown And Bridge, Long-Term Temporary, Resin
510(k) Number K261456
Device Name Ruthinium Disc
Applicant
Dental Manufacturing S.p.A.
Via Cà Mignola Nuova 1699
Badia Polesine,  IT 45021
Applicant Contact Barbara Piazza
Correspondent
Ruthinium USA
2365 Chesterfield Dr.
Kronenwetter,  WI  54455
Correspondent Contact Celline Souza Lakus
Regulation Number872.3770
Classification Product Code
POW  
Subsequent Product Code
EBG  
Date Received05/01/2026
Decision Date 08/05/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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