510(k) Report

510(k) · Cleared

Cleared

Perfect Choice Prophy Paste with 10% Carbamide Peroxide

K962370510(k) TraditionalCleared Mar 31, 1997285-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 Mar 31, 1997 as substantially equivalent to K940496 (Challenge Products, Inc., 1994) after a 285-day review. Its family tree reaches back 1 generation to 1994.

Decided
Mar 31, 1997
Review
285 days
Class
Class I
Product code
EJR
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K940496 (1994). No later device cites it as a predicate yet.

K940496 · Prophy Paste · Challenge Products, Inc. · 199419901992199419961998
K940496 · Prophy Paste · Challenge Products, Inc. · 19940
  1. Root · 1 generation backK940496 Prophy PasteChallenge Products, Inc. · 1994
  2. This deviceK962370 Perfect Choice Prophy Paste with 10% Carbamide PeroxideChallenge Products, Inc. · 1997
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K940496Prophy PasteChallenge Products, Inc.1994—
0 (this device)K962370Perfect Choice Prophy Paste with 10% Carbamide PeroxideChallenge Products, Inc.1997—
FIG. 1 — Lineage of K962370, 1994–1997Source: 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K940496Prophy Paste
Summary page 1
…Name of the Device The device is generally known as a prophy paste. 3. Identification of Predicate Device(s) Challenge Products, Inc. Prophy Paste, FDA control number K940496. 4. Description of the Device The device is a prophy paste which is used by dental professionals to help remove resistant stains…
Challenge Products, Inc.1994—

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?

  • Its one ancestor has no 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?

The intended use of the prophy paste is to help remove materia alba, plaque and resistant stains from the teeth.

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

More from Challenge Products, Inc.

4 FDA decisions under this applicant name. See the company

  • K940496Prophy PasteChallenge Products, Inc. · 1994
  • K884245Perfect ChoiceChallenge Products, Inc. · 1989
  • K853248Challenger SunriseChallenge Products, Inc. · 1985

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/K962370 · printed Nov 6, 2026

Cite this page

510(k) Report. “K962370: Perfect Choice Prophy Paste with 10% Carbamide Peroxide.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K962370

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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