510(k) · Cleared

Cleared

LCR

K052235510(k) SpecialCleared Sep 27, 200541-day reviewClass II21 CFR 872.3275

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

Cleared on Sep 27, 2005 as substantially equivalent to K925032 (3M Company, 1992) and 2 other predicates after a 41-day review. Its family tree reaches back 1 generation to 1992. 6 later devices descend from it.

Decided: Sep 27, 2005
Review: 41 days
Class: Class II
Product code: EMA
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K925032 (1992). 3 ancestors in all. 6 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK925032 3M Vitremer Tri-Cure Glass Ionomer System3M Company · 1992
This deviceK052235 LCR3M Company · 2005
Descendant · cites it directly · 4 of its ownK130223 Rmgi FillPulpdent Corporation · 2013
Descendant · 2 generations on · 1 of its ownK153249 Pulpdent Solo Flowable Composite with MCPPulpdent Corporation · 2016
Descendant · 2 generations on · 0 of its ownK250953 Equia LC OneGC America, Inc. · 2025
Descendant · 3 generations on · 0 of its ownK210045 Activa Presto PackPulpdent Corporation · 2021
Descendant · 2 generations on · 0 of its ownK192530 Surefil one Self-adhesive Composite HybridDentsply Sirona · 2020

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2013high 2 (2016) · low 0 (2014)2026

Most influential descendants

Showing 5 of 6 · See all

K130223Rmgi FillPulpdent Corporation · 2013 · cites it directly4descendants
K153249Pulpdent Solo Flowable Composite with MCPPulpdent Corporation · 2016 · 2 generations on1descendant
K250953Equia LC OneGC America, Inc. · 2025 · 2 generations on0descendants
K210045Activa Presto PackPulpdent Corporation · 2021 · 3 generations on0descendants
K192530Surefil one Self-adhesive Composite HybridDentsply Sirona · 2020 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K925032	3M Vitremer Tri-Cure Glass Ionomer System	3M Company	1992	—
0 (this device)	K052235	LCR	3M Company	2005	—
+1	K130223	Rmgi Fill	Pulpdent Corporation	2013	—
+2	K153249	Pulpdent Solo Flowable Composite with MCP	Pulpdent Corporation	2016	—
+2	K250953	Equia LC One	GC America, Inc.	2025	—
+3	K210045	Activa Presto Pack	Pulpdent Corporation	2021	—
+2	K192530	Surefil one Self-adhesive Composite Hybrid	Dentsply Sirona	2020	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1993	1	0
2000	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2013	1	0
2016	2	0
2020	1	0
2021	1	0
2025	1	0

FIG. 1 — Lineage of K052235, 1992–2025Source: 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 EMA? 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 EMA device

#1 K254109 G-Cem Universalscore 15.0 · 13 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? (3)

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
*	K925032	3M Vitremer Tri-Cure Glass Ionomer System Summary page 1 …me: .............. Dental Cement Common Name:..................Glass lonomer Restorative Predicate Devices: Vitremer Core Buildup/Restorative System.....K925032 Photac-Fil Aplicap .................. K925027 Fujii Il LC.............................K993973 LCR is…	3M Company	1992	—
*	K925027	Photac-Fil Aplicap Summary page 1 …......Glass lonomer Restorative Predicate Devices: Vitremer Core Buildup/Restorative System.....K925032 Photac-Fil Aplicap .................. K925027 Fujii Il LC.............................K993973 LCR is classified as a Dental Cement (21 C.F.R. § 872.3275) because it is…	Espe GmbH (Us)	1993	—
*	K993973	Fuji II LC Capsule Summary page 1 …Vitremer Core Buildup/Restorative System.....K925032 Photac-Fil Aplicap .................. K925027 Fujii Il LC.............................K993973 LCR is classified as a Dental Cement (21 C.F.R. § 872.3275) because it is a resin modified glass ionomer base cement used as a…	GC America, Inc.	2000	—

Also cleared against K925032: 1 other device →

What descends from it? (6)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K130223	Rmgi Fill	Pulpdent Corporation	2013	4
K152652	PackFil Dual Cured Resin Modified Glass Ionomer Restorative Cement	Gaia Dental Products, Inc.	2016	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?

None of the 3 ancestors has a recall.
Of its descendants, K130223 (Pulpdent Corporation, 2013) has gone furthest, with 4 descendants of its own.
1 other device also cites its predicate K925032.

How does its category compare?

All EMA devices

EMA Cement, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EMA

10in 2025

2007high 14 (2010) · low 2 (2023)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EMA

106in 2025

2007high 245 (2022) · low 48 (2007)2026

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

Recalls per year · EMA

1in 2023

2007high 5 (2011) · low 0 (2007)2026

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

Adverse event reports per year · EMA

9in 2025

2007high 385 (2013) · low 3 (2022)2025

MAUDE reports naming product code EMA, 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	6	48	0	33
2008	13	71	2	50
2009	10	86	1	90
2010	14	86	1	106
2011	8	79	5	224
2012	10	128	0	249
2013	12	178	0	385
2014	4	174	0	207
2015	9	134	0	85
2016	10	182	0	16
2017	3	141	0	13
2018	3	237	0	4
2019	7	127	0	12
2020	8	164	0	5
2021	4	184	0	8
2022	7	245	0	3
2023	2	—	1	6
2024	3	59	0	5
2025	10	106	0	9
2026	7	150	0	—

What is it indicated for?

Primary teeth restorations

Small Class I restorations

Class III and Class V restorations

Transitional restorations

Filling defects and undercut areas in crown preparations

Core buildup where at least half the coronal tooth structure is remaining to provide structural support for the crown

Laminate sandwich technique

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K052235 · printed Nov 4, 2026

Cite this page

510(k) Report. “K052235: LCR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K052235

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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

LCR