510(k) · Cleared

Cleared

Zone, ZoneFree, Zone A1

K151526510(k) TraditionalCleared Sep 10, 201594-day reviewClass II21 CFR 872.3275

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

Sybron Dental Specialties · EMA Cement, Dental

Cleared on Sep 10, 2015 as substantially equivalent to K003658 (Sybron Dental Specialties, Inc., 2001) after a 94-day review. Its family tree reaches back 1 generation to 2001.

Decided: Sep 10, 2015
Review: 94 days
Class: Class II
Product code: EMA
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K003658 (2001). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK003658 Temp-Bond NE 2Sybron Dental Specialties, Inc. · 2001
This deviceK151526 Zone, ZoneFree, Zone A1Sybron Dental Specialties · 2015

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K003658	Temp-Bond NE 2	Sybron Dental Specialties, Inc.	2001	—
0 (this device)	K151526	Zone, ZoneFree, Zone A1	Sybron Dental Specialties	2015	—

FIG. 1 — Lineage of K151526, 2001–2015Source: 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 EMA? 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 EMA device

#1 K254109 G-Cem Universalscore 15.0 · 13 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
*	K003658	Temp-Bond NE 2 Summary page 4 …redicate Device: Zone, Zone A1 and ZoneFree are substantially equivalent to the legally marketed device Temp-Bond NE 2 Temporary Zinc Oxide Non-Eugenol Cement (K003658) cleared on January 4, 2001, product code EMA. 4. Description of Device: Zone, Zone A1 and ZoneFree are Zinc Oxide N…	Sybron Dental Specialties, Inc.	2001	—

Also cleared against K003658: 1 other device →

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.
1 other device also cites its predicate K003658.

How does its category compare?

All EMA devices

EMA Cement, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.

FDA decisions per year · EMA

10in 2025

2007high 14 (2010) · low 2 (2023)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EMA

106in 2025

2007high 245 (2022) · low 48 (2007)2026

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

Recalls per year · EMA

1in 2023

2007high 5 (2011) · low 0 (2007)2026

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

Adverse event reports per year · EMA

9in 2025

2007high 385 (2013) · low 3 (2022)2025

MAUDE reports naming product code EMA, 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	6	48	0	33
2008	13	71	2	50
2009	10	86	1	90
2010	14	86	1	106
2011	8	79	5	224
2012	10	128	0	249
2013	12	178	0	385
2014	4	174	0	207
2015	9	134	0	85
2016	10	182	0	16
2017	3	141	0	13
2018	3	237	0	4
2019	7	127	0	12
2020	8	164	0	5
2021	4	184	0	8
2022	7	245	0	3
2023	2	—	1	6
2024	3	59	0	5
2025	10	106	0	9
2026	7	150	0	—

What is it indicated for?

Zone/Zone A1 and ZoneFree are Zinc Oxide Non-Eugenol temporary cements used for the cementation of temporary restorations.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K151526 · printed Nov 6, 2026

Cite this page

510(k) Report. “K151526: Zone, ZoneFree, Zone A1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151526

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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