510(k) · Cleared

Cleared

Prophy Paste

K940496510(k) TraditionalCleared Apr 19, 199476-day reviewClass I21 CFR 872.6030

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

Challenge Products, Inc. · EJR Agent, Polishing, Abrasive, Oral Cavity

Cleared on Apr 19, 1994 after a 76-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 later device descends from it.

Decided: Apr 19, 1994
Review: 76 days
Class: Class I
Product code: EJR
Recalls: None
Predicates: 0

1 later device descends from it, 1 citing it directly.

This deviceK940496 Prophy PasteChallenge Products, Inc. · 1994
Descendant · cites it directly · 0 of its ownK962370 Perfect Choice Prophy Paste with 10% Carbamide PeroxideChallenge Products, Inc. · 1997

Most influential descendants

Showing 1 of 1 · See all

K962370Perfect Choice Prophy Paste with 10% Carbamide PeroxideChallenge Products, Inc. · 1997 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K940496	Prophy Paste	Challenge Products, Inc.	1994	—
+1	K962370	Perfect Choice Prophy Paste with 10% Carbamide Peroxide	Challenge Products, Inc.	1997	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0

FIG. 1 — Lineage of K940496, 1994–1997Source: 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 EJR? 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

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
K962370	Perfect Choice Prophy Paste with 10% Carbamide Peroxide	Challenge Products, Inc.	1997	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?

Of its descendants, K962370 (Challenge Products, Inc., 1997) has gone furthest, with 0 descendants of its own.

How does its category compare?

All EJR devices

EJR Agent, Polishing, Abrasive, Oral Cavity: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EJR

1in 2017

2007high 2 (2010) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EJR

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

Recalls per year · EJR

No recall names EJR since 2007.

Adverse event reports per year · EJR

4in 2025

2007high 10 (2015) · low 0 (2008)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	1	—	6
2008	0	—	0
2009	0	—	2
2010	2	—	3
2011	2	—	1
2012	1	—	3
2013	0	—	9
2014	1	—	2
2015	0	—	10
2016	0	—	9
2017	1	—	3
2018	0	—	0
2019	0	—	8
2020	0	—	3
2021	0	—	6
2022	0	—	2
2023	0	—	3
2024	0	—	0
2025	0	—	4
2026	0	—	—

https://510kreport.com/device/K940496 · printed Nov 6, 2026

Cite this page

510(k) Report. “K940496: Prophy Paste.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K940496

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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