510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K261456Substantially Equivalent

Ruthinium Disc

Dental Manufacturing SpA, Badia Polesine, IT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K261456 is the FDA 510(k) clearance record for Ruthinium Disc, a class II device, cleared for Dental Manufacturing S.p.A. on under FDA product code POW (Crown And Bridge, Long-Term Temporary, Resin). FDA's definition for product code POW reads: "For the fabrication of long-term temporary crowns and bridges". FDA records list 2 510(k) clearances for Dental Manufacturing S.p.A., from to . As of , FDA records show no recalls naming K261456.

Clearance record

Decision date
Received
(96 days to decision)
Product code
POW Crown And Bridge, Long-Term Temporary, Resin
Regulation
21 CFR 872.3770
Device class
Class II
Review panel
Dental
Applicant
Dental Manufacturing S.p.A. Via Cà Mignola Nuova 1699, Badia Polesine, IT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code POW

Trailing 12 months
1 clearance under product code POW in the twelve months to October 2026, August 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code POW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260