510(k) Report

510(k) · Cleared

Cleared

Zircon-F Prophylaxis Paste

K040988510(k) TraditionalCleared Jul 7, 200483-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

Pascal Co., Inc. · EJR Agent, Polishing, Abrasive, Oral Cavity

Cleared on Jul 7, 2004 as substantially equivalent to K033449 (Professional Dental Technologies Therapeutics, Inc., 2004) and 2 other predicates after an 83-day review. Its family tree reaches back 2 generations to 2000.

Decided
Jul 7, 2004
Review
83 days
Class
Class I
Product code
EJR
Recalls
None
Predicates
3

Its longest line of descent runs back 2 generations to K002989 (2000). 5 ancestors in all, the oldest K912945 (1991). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2004: 1 other ancestor2000: 1 other ancestor1991: 1 other ancestorK002989 · Proclude · Ortek Therapeutics, Inc. · 2000K024343 · Butler Gum Prophy Paste with Novamin · Usbiomaterials Corp. · 20031990199520002005
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 1 other ancestor K024343 · Butler Gum Prophy Paste with Novamin · Usbiomaterials Corp. · 2003K002989 · Proclude · Ortek Therapeutics, Inc. · 20000
  1. Root · 2 generations backK002989 ProcludeOrtek Therapeutics, Inc. · 2000
  2. 1 generation backK024343 Butler Gum Prophy Paste with NovaminUsbiomaterials Corp. · 2003
  3. This deviceK040988 Zircon-F Prophylaxis PastePascal Co., Inc. · 2004
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K002989ProcludeOrtek Therapeutics, Inc.2000—
−1K024343Butler Gum Prophy Paste with NovaminUsbiomaterials Corp.2003—
0 (this device)K040988Zircon-F Prophylaxis PastePascal Co., Inc.2004—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199110
200010
200410
FIG. 1 — Lineage of K040988, 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), 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? (3)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K033449Pro-Dentec Double-Pro Prophylaxis Paste with Fluoide Family of Devices
Summary page 1
…products that are currently on the market, having been cleared by 510(k)s: 510(k) Number Name of Device Company K033449 Double-Pro Professional Dental K024343 Butler Gum Prophy…
Professional Dental Technologies Therapeutics, Inc.2004—
*K024343Butler Gum Prophy Paste with Novamin
Summary page 1
…ber Name of Device Company K033449 Double-Pro Professional Dental K024343 Butler Gum Prophy Paste USBiomaterials Corp. K000169 Nupro Prophylaxi…
Usbiomaterials Corp.2003—
*K000169Nupro Prophylaxis Paste with Fluoride and Triclosan
Summary page 1
…Double-Pro Professional Dental K024343 Butler Gum Prophy Paste USBiomaterials Corp. K000169 Nupro Prophylaxis Paste Dentsply Intl. 9) The document, "Guidance on the CDRH Premarket…
Dentsply Intl.2000—

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 4 years and passes through 3 companies; a new generation was cleared every 2.6 years on median.
  • None of the 5 ancestors has a recall.

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—

What is it indicated for?

To be used for cleaning and polishing procedures as part of a professionally administered dental prophylaxis treatment.

Indications for use as stated in the FDA summary.

More from Pascal Co., Inc.

8 FDA decisions under this applicant name. See the company

  • K102526BLO2X Oxygen BlockerPascal Co., Inc. · 2010
  • K090597Fluorilaq Sodium Fluoride Cavity VarnishPascal Co., Inc. · 2009
  • K040661Radent Prophy PastePascal Co., Inc. · 2004
  • K012889Banicide Liquid Chemical Sterilant/High-Level DisinfectantPascal Co., Inc. · 20031 recall
  • K030488FluorilaqPascal Co., Inc. · 2003

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/K040988 · printed Nov 5, 2026

Cite this page

510(k) Report. “K040988: Zircon-F Prophylaxis Paste.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K040988

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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