510(k) · Cleared

Cleared

Ruthinium Disc

K261456510(k) TraditionalCleared Aug 5, 202696-day reviewClass II21 CFR 872.3770

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Dental Manufacturing S.p.A. · POW Crown And Bridge, Long-Term Temporary, Resin

Cleared on Aug 5, 2026 as substantially equivalent to K172281 (Quest Dental USA Corp., 2017) after a 96-day review. Its family tree reaches back 2 generations to 2010.

Decided: Aug 5, 2026
Review: 96 days
Class: Class II
Product code: POW
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K093708 (2010). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK093708 Telio CadIvoclar Vivadent, Inc. · 2010
1 generation backK172281 PuRE PMMA DiscQuest Dental USA Corp. · 2017
This deviceK261456 Ruthinium DiscDental Manufacturing S.p.A. · 2026

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K093708	Telio Cad	Ivoclar Vivadent, Inc.	2010	—
−1	K172281	PuRE PMMA Disc	Quest Dental USA Corp.	2017	—
0 (this device)	K261456	Ruthinium Disc	Dental Manufacturing S.p.A.	2026	—

FIG. 1 — Lineage of K261456, 2010–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in POW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K172281	PuRE PMMA Disc Summary page 5 …icate Devices (807.92(a)(3)) The subject device is substantially equivalent to the following legally marketed devices: Primary Predicate Device: K172281 – PuRE PMMA Disc 5.4. Device Description (807.92(a)(4)) The Ruthinium Disc is a pre-polymerized polymethyl methacrylate (PMMA) C…	Quest Dental USA Corp.	2017	—

Also cleared against K172281: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 8.8 years on median.
None of the 2 ancestors has a recall.
1 other device also cites its predicate K172281.

How does its category compare?

All POW devices

POW Crown And Bridge, Long-Term Temporary, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.

FDA decisions per year · POW

1in 2023

2007high 1 (2023) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · POW

Too few POW 510(k)s in any year since 2007 to give a median.

Recalls per year · POW

No recall names POW since 2007.

Adverse event reports per year · POW

1in 2022

2007high 1 (2022) · low 0 (2007)2025

MAUDE reports naming product code POW, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	0	—	0
2019	0	—	0
2020	0	—	0
2021	0	—	0
2022	0	—	1
2023	1	—	0
2024	0	—	0
2025	0	—	0
2026	1	—	—

What is it indicated for?

The Ruthinium Disc is a polymethyl methacrylate (PMMA) blank intended for use in CAD/CAM systems for the fabrication of long-term temporary crowns and bridges, until permanent restorations can be delivered.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K261456 · printed Nov 6, 2026

Cite this page

510(k) Report. “K261456: Ruthinium Disc.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261456

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded Oct 30, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026