510(k) · Cleared

Recalled · Class II · 2024

Transcend

K201795510(k) AbbreviatedCleared Sep 28, 202090-day reviewClass II21 CFR 872.3690Recalls 2

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

Ultradent Product, Inc. · EBF Material, Tooth Shade, Resin

Cleared on Sep 28, 2020 as substantially equivalent to K043119 (Ultradent Products, Inc., 2004) after a 90-day review. Its family tree reaches back 1 generation to 2004. 1 later device descends from it. It has been recalled 2 times.

Decided: Sep 28, 2020
Review: 90 days
Class: Class II
Product code: EBF
Recalls: 2
Predicates: 1

Its longest line of descent runs back 1 generation to K043119 (2004). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK043119 Amelogen PlusUltradent Products, Inc. · 2004
This deviceK201795 TranscendUltradent Product, Inc. · 2020
Descendant · cites it directly · 0 of its ownK262228 Transcend Bulk Fill Flowable CompositeUltradent Products, Inc. · 2026

Most influential descendants

Showing 1 of 1 · See all

K262228Transcend Bulk Fill Flowable CompositeUltradent Products, Inc. · 2026 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K043119	Amelogen Plus	Ultradent Products, Inc.	2004	—
0 (this device)	K201795	Transcend	Ultradent Product, Inc.	2020	—
+1	K262228	Transcend Bulk Fill Flowable Composite	Ultradent Products, Inc.	2026	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2026	1	0

FIG. 1 — Lineage of K201795, 2004–2026Source: 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 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

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
*	K043119	Amelogen Plus Summary page 5 …2 V. Predicate Device The predicate device for Transcend, Amelogen Plus, is cleared under 510(k) K043119. The predicate device is also manufactured and distributed by Ultradent Products, Inc. The reference device for the subject acce…	Ultradent Products, Inc.	2004	—
†	K092539	Seamfree	Apex Dental Materials, Inc.	2009	—

Also cleared against K043119: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K262228	Transcend Bulk Fill Flowable Composite	Ultradent Products, Inc.	2026	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Aug 2, 2024	Class II	Z-3068-2024	Material/Component Contamination	Due to a manufacturing issue, red particulates present in the expressed composite.
Aug 2, 2024	Class II	Z-3067-2024	Material/Component Contamination	Due to a manufacturing issue, red particulates present in the expressed composite.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K262228 (Ultradent Products, Inc., 2026) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K043119.

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. 2020, 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?

Transcend universal composite is used for direct and indirect restorations in both the anterior and posterior regions.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K201795 · printed Nov 3, 2026

Cite this page

510(k) Report. “K201795: Transcend.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K201795

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Record history

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