510(k) · Cleared

Cleared

Nupro Sensodyne Prophylaxis Paste with Novamin

K121698510(k) TraditionalCleared Aug 6, 201259-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

Dentsply International, Inc. · EJR Agent, Polishing, Abrasive, Oral Cavity

Cleared on Aug 6, 2012 as substantially equivalent to K024343 (Usbiomaterials Corp., 2003) after a 59-day review. Its family tree reaches back 2 generations to 2000.

Decided: Aug 6, 2012
Review: 59 days
Class: Class I
Product code: EJR
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K002989 (2000). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK002989 ProcludeOrtek Therapeutics, Inc. · 2000
1 generation backK024343 Butler Gum Prophy Paste with NovaminUsbiomaterials Corp. · 2003
This deviceK121698 Nupro Sensodyne Prophylaxis Paste with NovaminDentsply International, Inc. · 2012

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K002989	Proclude	Ortek Therapeutics, Inc.	2000	—
−1	K024343	Butler Gum Prophy Paste with Novamin	Usbiomaterials Corp.	2003	—
0 (this device)	K121698	Nupro Sensodyne Prophylaxis Paste with Novamin	Dentsply International, Inc.	2012	—

FIG. 1 — Lineage of K121698, 2000–2012Source: 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 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? (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
*	K024343	Butler Gum Prophy Paste with Novamin Summary page 1 …30 Device Class:I Product Code: EJR 3.0 Predicate Device Butler Prophylaxis Paste with NovaMin, product code EJR, K024343 Indications for Use - Butler Prophylaxis Paste with NovaMin®)is intended for cleaning and polishing procedure…	Usbiomaterials Corp.	2003	—

Also cleared against K024343: 4 other devices →

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?

The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 9.1 years on median.
None of the 2 ancestors has a recall.
4 other devices also cite its predicate K024343.

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. 2012, this device’s year, is highlighted.

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	—	—

What is it indicated for?

NUPRO® Sensodyne® Prophylaxis Paste with NovaMin® is intended for cleaning and polishing procedures, including prior to and after scaling and root planing as part of a professionally administered dental prophylaxis treatment. Secondarily, NUPRO® Sensodyne® Prophylaxis Paste with NovaMin® can be used for the immediate relief of tooth sensitivity and for lasting sensitivity relief for up to 4 weeks (28 days) after just one application.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K121698 · printed Nov 6, 2026

Cite this page

510(k) Report. “K121698: Nupro Sensodyne Prophylaxis Paste with Novamin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121698

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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