510(k) · Cleared

Cleared

Flex Fit

K190790510(k) TraditionalCleared Jul 31, 2020492-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

Dk Mungyo Corporation · EBI Resin, Denture, Relining, Repairing, Rebasing

Cleared on Jul 31, 2020 as substantially equivalent to K113608 (Nuxen S.R.L., 2012) after a 492-day review. Its family tree reaches back 2 generations to 2006.

Decided: Jul 31, 2020
Review: 492 days
Class: Class II
Product code: EBI
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K053060 (2006). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK053060 TCS UnbreakableThermoplastic Comfort Systems, Inc. · 2006
1 generation backK113608 DeflexNuxen S.R.L. · 2012
This deviceK190790 Flex FitDk Mungyo Corporation · 2020

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K053060	TCS Unbreakable	Thermoplastic Comfort Systems, Inc.	2006	—
−1	K113608	Deflex	Nuxen S.R.L.	2012	—
0 (this device)	K190790	Flex Fit	Dk Mungyo Corporation	2020	—

FIG. 1 — Lineage of K190790, 2006–2020Source: 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

Get a 510(k) Report

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
*	K113608	Deflex Summary page 4 …• Classification Name: Denture Relining, Repairing, or Rebasing Resin • Product Code: EBI 4. Predicate Device • Primary Predicate Device: DEFLEX / K113608 • Reference Devices: ▪ ACRYTONE, REZEN NF, AND ISO FAST DENTURE RESINS / K130680 ▪ TCS UNBREAKABLE / K053060…	Nuxen S.R.L.	2012	—
†	K130680	Acrytone, Rezen NF, and Iso Fast Denture Resins	Dentsoll, Inc.	2013	—
†	K053060	TCS Unbreakable	Thermoplastic Comfort Systems, Inc.	2006	—
†	K072479	Flexite Supreme, Flexite Plus, Flexite M.P., Northern and Flexite Pro-Guard	Rapid Injection Systems Corp.	2007	—

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 14 years and passes through 3 companies; a new generation was cleared every 8.3 years on median.
None of the 2 ancestors has a recall.

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. 2020, 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?

This product is indicated for the manufacturing of bases of partial or full removable dentures, occlusal splints and night guards through heating and pneumatic injection of the material, following the Instructions of Use that come with the product.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K190790 · printed Nov 5, 2026

Cite this page

510(k) Report. “K190790: Flex Fit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K190790

Report an extraction error

Are you the manufacturer?

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