510(k) · Cleared

Cleared

Chairside Attachment Processing Material

K140570510(k) TraditionalCleared Jun 16, 2014102-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

Zest Anchors, LLC · EBI Resin, Denture, Relining, Repairing, Rebasing

Cleared on Jun 16, 2014 as substantially equivalent to K110440 (Voco GmbH, 2011) and 3 other predicates after a 102-day review. Its family tree reaches back 1 generation to 2001.

Decided: Jun 16, 2014
Review: 102 days
Class: Class II
Product code: EBI
Recalls: None
Predicates: 4

Its longest line of descent runs back 1 generation to K011211 (2001). 4 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK011211 Flowable Composite/ Ecuflow/ LuxaflowDmg USA, Inc. · 2001
This deviceK140570 Chairside Attachment Processing MaterialZest Anchors, LLC · 2014

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K011211	Flowable Composite/ Ecuflow/ Luxaflow	Dmg USA, Inc.	2001	—
0 (this device)	K140570	Chairside Attachment Processing Material	Zest Anchors, LLC	2014	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2009	1	0
2011	1	0

FIG. 1 — Lineage of K140570, 2001–2014Source: 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? (4)

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
*	K110440	Quick UP Summary page 2 …el of the patient's mouth). EQUIVALENCE TO MARKETED DEVICE The subject device is substantially equivalent to the following predicate devices: * VOCO GmbH, Quick Up (K 110440) * IMTEC Corporation, SECURE (K021586) * Danville Materials, Inc., Starfill 2B HV, Starfill 28 LV (K0929 12) * DM0 USA,…	Voco GmbH	2011	—
*	K021586	Secure Reline/Pickup Material Summary page 2 …O MARKETED DEVICE The subject device is substantially equivalent to the following predicate devices: * VOCO GmbH, Quick Up (K 110440) * IMTEC Corporation, SECURE (K021586) * Danville Materials, Inc., Starfill 2B HV, Starfill 28 LV (K0929 12) * DM0 USA, Inc., Flowable Composite (K01 121 1) The…	Imtec Corp.	2002	—
*	K092912	Starfill 2B HV (High Viscosity) Rockcore, Model: 90838 and Starfill 2B LV (Low… Summary page 2 …following predicate devices: * VOCO GmbH, Quick Up (K 110440) * IMTEC Corporation, SECURE (K021586) * Danville Materials, Inc., Starfill 2B HV, Starfill 28 LV (K0929 12) * DM0 USA, Inc., Flowable Composite (K01 121 1) The subject device, Chairside Attachment Processing Material, has a similar…	Danville Materials, Inc.	2009	—
*	K011211	Flowable Composite/ Ecuflow/ Luxaflow Summary page 2 …k Up (K 110440) * IMTEC Corporation, SECURE (K021586) * Danville Materials, Inc., Starfill 2B HV, Starfill 28 LV (K0929 12) * DM0 USA, Inc., Flowable Composite (K01 121 1) The subject device, Chairside Attachment Processing Material, has a similar formula to the device cleared in K0929 12. The subj…	Dmg USA, Inc.	2001	—

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?

None of the 4 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. 2014, 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?

Chairsidee Attachment Processing Material is a dual cure (either self or UV light) pink

composite used to process attachments into dentures in a chairside or laboratory procedure.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K140570 · printed Nov 6, 2026

Cite this page

510(k) Report. “K140570: Chairside Attachment Processing Material.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140570

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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