510(k) · Cleared

Cleared

Sofreliner Tough S

K112445510(k) TraditionalCleared Oct 28, 201165-day reviewClass II21 CFR 872.3760

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

Tokuyama Dental Corporation · EBI Resin, Denture, Relining, Repairing, Rebasing

Cleared on Oct 28, 2011 as substantially equivalent to K982537 (Tokuyama America, Inc., 1998) and 2 other predicates after a 65-day review. Its family tree reaches back 2 generations to 1996.

Decided: Oct 28, 2011
Review: 65 days
Class: Class II
Product code: EBI
Recalls: None
Predicates: 3

Its longest line of descent runs back 2 generations to K953589 (1996). 4 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK953589 Tokuyama Soft ReliningTokuyama America, Inc. · 1996
1 generation backK030663 Tokuyama Sofreliner ToughTokuyama Dental Corporation · 2003
This deviceK112445 Sofreliner Tough STokuyama Dental Corporation · 2011

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K953589	Tokuyama Soft Relining	Tokuyama America, Inc.	1996	—
−1	K030663	Tokuyama Sofreliner Tough	Tokuyama Dental Corporation	2003	—
0 (this device)	K112445	Sofreliner Tough S	Tokuyama Dental Corporation	2011	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
1999	1	0

FIG. 1 — Lineage of K112445, 1996–2011Source: 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 EBI? 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 EBI device

#1 K250617 Apex Flexscore 18.3 · 1 generation · 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? (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
*	K982537	Tokuyama Sofreliner Summary page 2 …vice is substantially equivalent for purposes of FDA medical device regulations to multiple predicate devices, namely Tokuyama's own TOKUYAMA SOFRELINER (K#982537), TOKUYAMA SOFRELINER TOUGH (K#030663), and GC America's GC RELINE ULTRA SOFT (K#990736). 807.92(a)(4) Th…	Tokuyama America, Inc.	1998	—
*	K030663	Tokuyama Sofreliner Tough Summary page 2 …of FDA medical device regulations to multiple predicate devices, namely Tokuyama's own TOKUYAMA SOFRELINER (K#982537), TOKUYAMA SOFRELINER TOUGH (K#030663), and GC America's GC RELINE ULTRA SOFT (K#990736). 807.92(a)(4) The SOFRELII'ER TOUGH S denture relining, repai…	Tokuyama Dental Corporation	2003	—
*	K990736	GC Reline Soft/Extra Soft Summary page 2 …dicate devices, namely Tokuyama's own TOKUYAMA SOFRELINER (K#982537), TOKUYAMA SOFRELINER TOUGH (K#030663), and GC America's GC RELINE ULTRA SOFT (K#990736). 807.92(a)(4) The SOFRELII'ER TOUGH S denture relining, repairing, or rebasing resin device is a prescription a…	GC America, Inc.	1999	—

Also cleared against K982537: 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 15 years and passes through 2 companies; a new generation was cleared every 8.4 years on median.
None of the 4 ancestors has a recall.
1 other device also cites its predicate K982537.

How does its category compare?

All EBI devices

EBI Resin, Denture, Relining, Repairing, Rebasing: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · EBI

11in 2025

2007high 11 (2011) · low 3 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EBI

79in 2025

2007high 283 (2020) · low 53 (2007)2026

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

Recalls per year · EBI

2in 2022

2007high 2 (2018) · low 0 (2007)2026

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

Adverse event reports per year · EBI

34in 2025

2007high 34 (2025) · low 1 (2024)2025

MAUDE reports naming product code EBI, 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	10	53	0	7
2008	6	124	0	2
2009	3	234	0	5
2010	4	95	0	4
2011	11	113	0	6
2012	3	85	0	9
2013	5	135	0	5
2014	5	102	0	9
2015	9	106	0	8
2016	7	147	0	9
2017	8	196	0	2
2018	5	158	2	2
2019	4	127	0	10
2020	6	283	0	8
2021	4	99	0	25
2022	11	154	2	2
2023	11	96	0	13
2024	9	90	0	1
2025	11	79	0	34
2026	7	87	0	—

What is it indicated for?

The SOFRELINER. TOUGH S denture relining, repairing, or rebasing resin device is for use as a denture reliner.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K112445 · printed Nov 3, 2026

Cite this page

510(k) Report. “K112445: Sofreliner Tough S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K112445

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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