510(k) · Cleared

Cleared

I.Flex by TCS

K123396510(k) TraditionalCleared Jan 10, 201366-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

Thermoplastic Comfort Systems, Inc. · EBI Resin, Denture, Relining, Repairing, Rebasing

Cleared on Jan 10, 2013 as substantially equivalent to K063626 (Cosmetic Dental Materials, Inc., 2007) after a 66-day review. Its family tree reaches back 1 generation to 2007.

Decided: Jan 10, 2013
Review: 66 days
Class: Class II
Product code: EBI
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K063626 (2007). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK063626 DuraflexCosmetic Dental Materials, Inc. · 2007
This deviceK123396 I.Flex by TCSThermoplastic Comfort Systems, Inc. · 2013

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K063626	Duraflex	Cosmetic Dental Materials, Inc.	2007	—
0 (this device)	K123396	I.Flex by TCS	Thermoplastic Comfort Systems, Inc.	2013	—

FIG. 1 — Lineage of K123396, 2007–2013Source: 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? (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
*	K063626	Duraflex Summary page 1 …(The Myerson Company, Ltd.) Device Name Duralex 510(k) Number K063626 Device Description i.flex by TCS is an injection moldable, flexible, thermoplastic resin provided with trace amounts of color…	Cosmetic Dental Materials, Inc.	2007	—

Also cleared against K063626: 3 other devices →

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?

Its one ancestor has no recall.
3 other devices also cite its predicate K063626.

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. 2013, 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?

i.flex by TCS is a thermoplastic resin used for the fabrication of partial or full removable dentures, as well as occlusal splints and night guards.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K123396 · printed Nov 5, 2026

Cite this page

510(k) Report. “K123396: I.Flex by TCS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K123396

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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