510(k) · Cleared

Cleared

Triumph Resin Dam

K151945510(k) TraditionalCleared Feb 18, 2016219-day reviewClass I21 CFR 872.6300

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

Cleared on Feb 18, 2016 as substantially equivalent to K971284 (Ultradent Products, Inc., 1997) after a 219-day review. Its family tree reaches back 1 generation to 1997. 1 later device descends from it.

Decided: Feb 18, 2016
Review: 219 days
Class: Class I
Product code: EIE
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K971284 (1997). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK971284 OpaldamUltradent Products, Inc. · 1997
This deviceK151945 Triumph Resin DamDenali Corporation · 2016
Descendant · cites it directly · 0 of its ownK182118 armor LCMavrik Dental Systems, Ltd. · 2019

Most influential descendants

Showing 1 of 1 · See all

K182118armor LCMavrik Dental Systems, Ltd. · 2019 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K971284	Opaldam	Ultradent Products, Inc.	1997	—
0 (this device)	K151945	Triumph Resin Dam	Denali Corporation	2016	—
+1	K182118	armor LC	Mavrik Dental Systems, Ltd.	2019	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2019	1	0

FIG. 1 — Lineage of K151945, 1997–2019Source: 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 EIE? 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

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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
*	K971284	Opaldam Summary page 4 …Product EIE REGISTRATION 3006367836 PRIMARY PREDICATE DEVICE OpalDam (k971284) Ultradent Products, Inc. REFERENCE PREDICATE DEVICE BriteSmile (k010935), BriteSmile Inc, EQUIVAL…	Ultradent Products, Inc.	1997	—
†	K010935	Britesmile Barrier Material	Britesmile, Inc.	2001	—

Also cleared against K971284: 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
K182118	armor LC	Mavrik Dental Systems, Ltd.	2019	0

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?

Its one ancestor has no recall.
Of its descendants, K182118 (Mavrik Dental Systems, Ltd., 2019) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K971284.

How does its category compare?

All EIE devices

EIE Dam, Rubber: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.

FDA decisions per year · EIE

1in 2019

2007high 1 (2016) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EIE

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

Recalls per year · EIE

No recall names EIE since 2007.

Adverse event reports per year · EIE

1in 2024

2007high 4 (2018) · low 0 (2007)2025

MAUDE reports naming product code EIE, 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	—	1
2010	0	—	1
2011	0	—	0
2012	0	—	1
2013	0	—	1
2014	0	—	0
2015	0	—	2
2016	1	—	1
2017	0	—	2
2018	0	—	4
2019	1	—	2
2020	0	—	0
2021	0	—	2
2022	0	—	1
2023	0	—	0
2024	0	—	1
2025	0	—	0
2026	0	—	—

What is it indicated for?

Triumph Resin Dam is a resin-based, light-cured protective barrier material recommended to protect dental materials or tissues.

For Use only by a Licensed Dentist. Rx Use Only.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K151945 · printed Nov 5, 2026

Cite this page

510(k) Report. “K151945: Triumph Resin Dam.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K151945

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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