510(k) Report

510(k) · Cleared

Cleared

Nupro Prophylaxis Paste with Fluoride and Triclosan

K000169510(k) TraditionalCleared Mar 24, 200064-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 Intl. · EJR Agent, Polishing, Abrasive, Oral Cavity

Cleared on Mar 24, 2000 after a 64-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided
Mar 24, 2000
Review
64 days
Class
Class I
Product code
EJR
Recalls
None
Predicates
0

2 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2004: 2 descendants cleared200020052010201520202025
  1. This deviceK000169 Nupro Prophylaxis Paste with Fluoride and TriclosanDentsply Intl. · 2000
  2. Descendant · cites it directly · 0 of its ownK040988 Zircon-F Prophylaxis PastePascal Co., Inc. · 2004
  3. Descendant · cites it directly · 0 of its ownK033785 Proactive Care Prophylaxis Paste with FluorideDiscus Dental, Inc. · 2004

Most influential descendants

Showing 2 of 2 · See all
  • K040988Zircon-F Prophylaxis PastePascal Co., Inc. · 2004 · cites it directly0descendants
  • K033785Proactive Care Prophylaxis Paste with FluorideDiscus Dental, Inc. · 2004 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K000169Nupro Prophylaxis Paste with Fluoride and TriclosanDentsply Intl.2000—
+1K040988Zircon-F Prophylaxis PastePascal Co., Inc.2004—
+1K033785Proactive Care Prophylaxis Paste with FluorideDiscus Dental, Inc.2004—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200420
FIG. 1 — Lineage of K000169, 2000–2004Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K040988Zircon-F Prophylaxis PastePascal Co., Inc.20040
K033785Proactive Care Prophylaxis Paste with FluorideDiscus Dental, Inc.20040

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, K040988 (Pascal Co., Inc., 2004) 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

2007: 12010: 22011: 22012: 12014: 12017: 1
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

2007: 62009: 22010: 32011: 12012: 32013: 92014: 22015: 102016: 92017: 32019: 82020: 32021: 62022: 22023: 32025: 4
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—06
20080—00
20090—02
20102—03
20112—01
20121—03
20130—09
20141—02
20150—010
20160—09
20171—03
20180—00
20190—08
20200—03
20210—06
20220—02
20230—03
20240—00
20250—04
20260—0—

More from Dentsply Intl.

279 FDA decisions under this applicant name. See the company

  • K123615Iris - High Strength Glass CeramicDentsply Intl. · 2013
  • K072730Friadent Cercon and Ankylos Cercon Balance AbutmentsDentsply Intl. · 2008
  • K070538XP Bond Dual Cure Universal Total Etch AdhesiveDentsply Intl. · 2007
  • K070019Carrara VolumiaDentsply Intl. · 2007
  • K061427Pre-Impression Conditioning SolutionDentsply Intl. · 2006

Recent decisions in EJR

The EJR category page

  • K171189AIR-FLOW PLUS Prophylaxis powderE.M.S Electro Medical Systems S.A · 2017
  • K131760Whip Mix Preppies PlusWhip-Mix Corp. · 2014
  • K121698Nupro Sensodyne Prophylaxis Paste with NovaminDentsply International, Inc. · 2012
  • K103114Osspray Sylc CROsspray, Ltd. · 2011
  • K102053Butler Calci-Flor Prophylaxis PasteSunstar Americas, Inc. · 2011

https://510kreport.com/device/K000169 · printed Nov 6, 2026

Cite this page

510(k) Report. “K000169: Nupro Prophylaxis Paste with Fluoride and Triclosan.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000169

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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