510(k) · Cleared

Cleared

Partial Flex

K242897510(k) TraditionalCleared Jun 3, 2025253-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

Clemde SA DE CV · EBI Resin, Denture, Relining, Repairing, Rebasing

Cleared on Jun 3, 2025 as substantially equivalent to K053060 (Thermoplastic Comfort Systems, Inc., 2006) after a 253-day review. Its family tree reaches back 1 generation to 2006.

Decided: Jun 3, 2025
Review: 253 days
Class: Class II
Product code: EBI
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K053060 (2006). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK053060 TCS UnbreakableThermoplastic Comfort Systems, Inc. · 2006
This deviceK242897 Partial FlexClemde SA DE CV · 2025

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K053060	TCS Unbreakable	Thermoplastic Comfort Systems, Inc.	2006	—
0 (this device)	K242897	Partial Flex	Clemde SA DE CV	2025	—

FIG. 1 — Lineage of K242897, 2006–2025Source: 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 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
*	K053060	TCS Unbreakable Summary page 5 …edicate devices already cleared by the FDA: Predicate Device 510(k) Number 510(k) Holder TCS UNBREAKABLE K053060 THERMOPLASTIC CONFORT SYSTEM 4. Description of the Device 4.1. Partial Flex Partial Flex® dental resin is a polymer b…	Thermoplastic Comfort Systems, Inc.	2006	—

Also cleared against K053060: 7 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.
7 other devices also cite its predicate K053060.

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. 2025, 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?

Partial Flex® is indicated for the fabrication of partial or full removable dentures, as well oclusional

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K242897 · printed Nov 4, 2026

Cite this page

510(k) Report. “K242897: Partial Flex.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K242897

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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