510(k) · Cleared

Cleared

Sureflex Files

K951607510(k) TraditionalCleared Jun 22, 199598-day reviewClass I21 CFR 872.4565

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

Dentsply Intl. · EKJ Burnisher, Operative

Cleared on Jun 22, 1995 after a 98-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided: Jun 22, 1995
Review: 98 days
Class: Class I
Product code: EKJ
Recalls: None
Predicates: 0

2 later devices descend from it, 1 citing it directly.

This deviceK951607 Sureflex FilesDentsply Intl. · 1995
Descendant · cites it directly · 1 of its ownK971603 Sterile Sureflex Files and InstrumentsDentsply Intl. · 1997
Descendant · 2 generations on · 0 of its ownK082325 Apexum AblatorApexum, Ltd. · 2009

Most influential descendants

Showing 2 of 2 · See all

K971603Sterile Sureflex Files and InstrumentsDentsply Intl. · 1997 · cites it directly1descendant
K082325Apexum AblatorApexum, Ltd. · 2009 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K951607	Sureflex Files	Dentsply Intl.	1995	—
+1	K971603	Sterile Sureflex Files and Instruments	Dentsply Intl.	1997	—
+2	K082325	Apexum Ablator	Apexum, Ltd.	2009	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
2009	1	0

FIG. 1 — Lineage of K951607, 1995–2009Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in EKJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K971603	Sterile Sureflex Files and Instruments	Dentsply Intl.	1997	1

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?

Of its descendants, K971603 (Dentsply Intl., 1997) has gone furthest, with 1 descendant of its own.

How does its category compare?

All EKJ devices

EKJ Burnisher, Operative: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EKJ

FDA has decided no EKJ device since 2007.

Median 510(k) review, days · EKJ

Too few EKJ 510(k)s in any year since 2007 to give a median.

Recalls per year · EKJ

No recall names EKJ since 2007.

Adverse event reports per year · EKJ

2in 2015

2007high 2 (2015) · low 0 (2007)2025

MAUDE reports naming product code EKJ, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	1
2012	—	0
2013	—	0
2014	—	0
2015	—	2
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

https://510kreport.com/device/K951607 · printed Nov 4, 2026

Cite this page

510(k) Report. “K951607: Sureflex Files.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K951607

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026