510(k) clearances

Ruthinium Disc

Dental Manufacturing S.p.A. · Dental

K261456Substantially EquivalentTraditionalPOW
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Third party flag
N
City
Badia Polesine
Advisory committee description
Dental
Address 1
Via Cà Mignola Nuova 1699
Statement or summary
Summary
Product code
POW
Zip code
45021
Applicant
Dental Manufacturing S.p.A.
Decision date
2026-08-05
Decision code
SESE
Country code
IT
Device name
Ruthinium Disc
Advisory committee
DE
Contact
Barbara Piazza
K number
K261456
Date received
2026-05-01
Review advisory committee
DE
Postal code
45021
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Crown And Bridge, Long-Term Temporary, Resin
Medical specialty description
Dental
Regulation number
872.3770
Device class
2
Registration number
8010908, 3001389926, 3008912871, 3010664129, 2023950, 3009482106, 3005942449, 3005904906, 3030515618, 8044164, 3007210751, 8031058
FEI number
3002718942, 3001389926, 3004150030, 3008912871, 3010664129, 2023950, 3009482106, 3005942449, 3005904906, 3030515618, 3007210751, 3002806651
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.