510(k) · Cleared

Cleared

Universal Opaque

K131504510(k) TraditionalCleared Jul 16, 201353-day reviewClass II21 CFR 872.3690

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

Shofu Dental Corporation · EBF Material, Tooth Shade, Resin

Cleared on Jul 16, 2013 after a 53-day review. FDA’s file for it is a 510(k) statement, which names no predicate.

Decided: Jul 16, 2013
Review: 53 days
Class: Class II
Product code: EBF
Recalls: None
Predicates: 0

FDA’s file for it is a 510(k) statement, which names no predicate.

FIG. 1 — Lineage of K131504Source: FDA 510(k) database · How lineage is built

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

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

Top candidate predicates for a new EBF device

#1 K202846 Tera Harzscore 18.5 · 7 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

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.

How does its category compare?

All EBF devices

EBF Material, Tooth Shade, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · EBF

15in 2025

2007high 20 (2009) · low 9 (2023)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EBF

43in 2025

2007high 205 (2016) · low 43 (2025)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · EBF

1in 2020

2007high 42 (2008) · low 0 (2012)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · EBF

1in 2025

2007high 246 (2013) · low 1 (2025)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	19	49	1	6
2008	14	79	42	10
2009	20	84	1	8
2010	19	75	6	31
2011	19	81	7	31
2012	11	86	0	62
2013	13	153	0	246
2014	10	112	0	195
2015	17	123	0	119
2016	20	205	0	143
2017	15	108	4	42
2018	15	115	0	8
2019	17	159	2	11
2020	15	190	1	2
2021	13	178	0	2
2022	17	63	0	2
2023	9	87	0	8
2024	18	120	0	5
2025	15	43	0	1
2026	16	59	2	—

What is it indicated for?

UNIVERSAL OPAQUE is a light-owing resin paste to be used for masking the substructure color of dental restorations.

1) Masking the metal color of facing crown

2) Masking the substructure color of jacket crown and laminate veneer etc.

3) Masking the substructure color of restorations and prostheses made of porcelain or crown and bridge composite resin etc. when repairing them intraorally or extraorally.

Indications for use as stated in the FDA 510(k) statement.

https://510kreport.com/device/K131504 · printed Nov 5, 2026

Cite this page

510(k) Report. “K131504: Universal Opaque.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K131504

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Page last updated Nov 3, 2026