510(k) · Cleared

Cleared

Stick Flow

K031341510(k) TraditionalCleared Oct 29, 2003184-day reviewClass II21 CFR 872.3690

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

Stick Tech, Ltd. · EBF Material, Tooth Shade, Resin

Cleared on Oct 29, 2003 as substantially equivalent to K955292 (Bisco, Inc., 1995) after a 184-day review. Its family tree reaches back 1 generation to 1995. 1 later device descends from it.

Decided: Oct 29, 2003
Review: 184 days
Class: Class II
Product code: EBF
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K955292 (1995). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK955292 AelitefloBisco, Inc. · 1995
This deviceK031341 Stick FlowStick Tech, Ltd. · 2003
Descendant · cites it directly · 0 of its ownK122348 Quartz Splint System (UD, Woven, Rope, Mesh) Quartz Spint Resin QS…Recherches Techniques Dentaires (R.T.D.) · 2012

Most influential descendants

Showing 1 of 1 · See all

K122348Quartz Splint System (UD, Woven, Rope, Mesh) Quartz Spint Resin QS FlowRecherches Techniques Dentaires (R.T.D.) · 2012 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K955292	Aeliteflo	Bisco, Inc.	1995	—
0 (this device)	K031341	Stick Flow	Stick Tech, Ltd.	2003	—
+1	K122348	Quartz Splint System (UD, Woven, Rope, Mesh) Quartz Spint Resin QS Flow	Recherches Techniques Dentaires (R.T.D.)	2012	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2012	1	0

FIG. 1 — Lineage of K031341, 1995–2012Source: 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 EBF? 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 EBF device

#1 K202846 Tera Harzscore 18.5 · 7 generations · 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
*	K955292	Aeliteflo Summary page 1 …d Use: For anterior and limited posterior restorations and sealings in dentistry StickTM Flow is substantially equivalent to AelitefloTM; approved under 51 O(k) nLmber K955292 dated December 13, 1995. { 4 8 &“‘mu, 0 s %a DEPARTMENT OF HEALTH & HUMAN SERVICES…	Bisco, Inc.	1995	—

Also cleared against K955292: 3 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K122348	Quartz Splint System (UD, Woven, Rope, Mesh) Quartz Spint Resin QS Flow	Recherches Techniques Dentaires (R.T.D.)	2012	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?

Its one ancestor has no recall.
Of its descendants, K122348 (Recherches Techniques Dentaires (R.T.D.), 2012) has gone furthest, with 0 descendants of its own.
3 other devices also cite its predicate K955292.

How does its category compare?

All EBF devices

EBF Material, Tooth Shade, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EBF

15in 2025

2007high 20 (2009) · low 9 (2023)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EBF

43in 2025

2007high 205 (2016) · low 43 (2025)2026

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

Recalls per year · EBF

1in 2020

2007high 42 (2008) · low 0 (2012)2026

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

Adverse event reports per year · EBF

1in 2025

2007high 246 (2013) · low 1 (2025)2025

MAUDE reports naming product code EBF, 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	19	49	1	6
2008	14	79	42	10
2009	20	84	1	8
2010	19	75	6	31
2011	19	81	7	31
2012	11	86	0	62
2013	13	153	0	246
2014	10	112	0	195
2015	17	123	0	119
2016	20	205	0	143
2017	15	108	4	42
2018	15	115	0	8
2019	17	159	2	11
2020	15	190	1	2
2021	13	178	0	2
2022	17	63	0	2
2023	9	87	0	8
2024	18	120	0	5
2025	15	43	0	1
2026	16	59	2	—

What is it indicated for?

A flowable light cure microhybrid composite for tooth filling, sealing and cementing.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K031341 · printed Nov 5, 2026

Cite this page

510(k) Report. “K031341: Stick Flow.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K031341

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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