510(k) · Cleared

Cleared

Simplicity

K020570510(k) TraditionalCleared Apr 24, 200262-day reviewClass II21 CFR 872.3200

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

Apex Dental Materials, Inc. · KLE Agent, Tooth Bonding, Resin

Cleared on Apr 24, 2002 as substantially equivalent to K945604 (Bisco, Inc., 1995) after a 62-day review. Its family tree reaches back 1 generation to 1995. 2 later devices descend from it.

Decided: Apr 24, 2002
Review: 62 days
Class: Class II
Product code: KLE
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K945604 (1995). 2 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK945604 EcliptomerBisco, Inc. · 1995
This deviceK020570 SimplicityApex Dental Materials, Inc. · 2002
Descendant · cites it directly · 1 of its ownK061981 SurpassApex Dental Materials, Inc. · 2006
Descendant · 2 generations on · 0 of its ownK093019 Enamelite Acryseal Spray SealantEnamelite, LLC · 2009

Most influential descendants

Showing 2 of 2 · See all

K061981SurpassApex Dental Materials, Inc. · 2006 · cites it directly1descendant
K093019Enamelite Acryseal Spray SealantEnamelite, LLC · 2009 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K945604	Ecliptomer	Bisco, Inc.	1995	—
0 (this device)	K020570	Simplicity	Apex Dental Materials, Inc.	2002	—
+1	K061981	Surpass	Apex Dental Materials, Inc.	2006	—
+2	K093019	Enamelite Acryseal Spray Sealant	Enamelite, LLC	2009	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2009	1	0

FIG. 1 — Lineage of K020570, 1995–2009Source: 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 KLE? 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 KLE device

#1 K262252 MPa Max adhesivescore 15.1 · 11 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
*	K945604	Ecliptomer Summary page 3 …rketed in the United States (see Confidential Formulation Details on page 5). Equivalent Product and Manufacturer Corresponding 510(k) Numbers ECLIPTOMER (Bisco, Inc.) K945604 e ‘“V"l'(r.o" s 5’ ( DEPARTMENT OF HEALTH & HUMAN SERVICES : Public Health Service bl S . : : T . FoodandDrug A…	Bisco, Inc.	1995	—

Also cleared against K945604: 3 other devices →

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
K061981	Surpass	Apex Dental Materials, Inc.	2006	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?

Its one ancestor has no recall.
Of its descendants, K061981 (Apex Dental Materials, Inc., 2006) has gone furthest, with 1 descendant of its own.
3 other devices also cite its predicate K945604.

How does its category compare?

All KLE devices

KLE Agent, Tooth Bonding, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KLE

3in 2025

2007high 14 (2007) · low 3 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KLE

149in 2025

2007high 195 (2020) · low 61 (2024)2026

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

Recalls per year · KLE

1in 2024

2007high 2 (2007) · low 0 (2008)2026

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

Adverse event reports per year · KLE

3in 2025

2007high 260 (2014) · low 3 (2025)2025

MAUDE reports naming product code KLE, 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	14	71	2	18
2008	3	66	0	9
2009	7	79	1	11
2010	8	93	1	13
2011	10	100	0	69
2012	5	66	0	176
2013	11	115	0	248
2014	6	120	0	260
2015	10	118	0	100
2016	3	148	1	47
2017	4	171	1	42
2018	8	124	0	31
2019	6	143	0	20
2020	6	195	0	6
2021	4	163	0	6
2022	8	98	0	7
2023	6	75	0	7
2024	7	61	1	12
2025	3	149	0	3
2026	7	84	0	—

What is it indicated for?

SIMPLICITY™ is a light cured (free radical polymerization), self-etching dental adhesive system, designed io provide a dentist with an increased ease of use that is less technique sensitive. The bonding system combines both the etchant and primer applications into -one simple step. Thus, allowing for more predictable clinical results without sacrificing bond strength integrity. SIMPLICITY™ is a universal adhesive system that when properly employed, can…

Read the full statement (141 words)

SIMPLICITY™ is a universal adhesive system that when properly employed, can be used to seal enamel/dentin prior to restoring with light cured or self cured composite materials. Also, in situations of indirect restorations, the bonding system can be used to seal a preparation when using a light cured, self cured or dual cured composite cement or glass ionomer or resin-modified glass ionomer cement. In addition, the system allows the dentist to bond a post and core, along with the use to treat hypersensitive and/or exposed root surfaces.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K020570 · printed Nov 5, 2026

Cite this page

510(k) Report. “K020570: Simplicity.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K020570

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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