510(k) · Cleared

Cleared

Pro-Dentec Double-Pro Prophylaxis Paste with Fluoide Family of Devices

K033449510(k) TraditionalCleared Jan 7, 200470-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

Professional Dental Technologies Therapeutics, Inc. · EJR Agent, Polishing, Abrasive, Oral Cavity

Cleared on Jan 7, 2004 as substantially equivalent to K912945 (Dentsply Intl., 1991) after a 70-day review. Its family tree reaches back 1 generation to 1991. 1 later device descends from it.

Decided: Jan 7, 2004
Review: 70 days
Class: Class I
Product code: EJR
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K912945 (1991). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK912945 Satin Prophylaxis PasteDentsply Intl. · 1991
This deviceK033449 Pro-Dentec Double-Pro Prophylaxis Paste with Fluoide Family of DevicesProfessional Dental Technologies Therapeutics, Inc. · 2004
Descendant · cites it directly · 0 of its ownK040988 Zircon-F Prophylaxis PastePascal Co., Inc. · 2004

Most influential descendants

Showing 1 of 1 · See all

K040988Zircon-F Prophylaxis PastePascal Co., Inc. · 2004 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K912945	Satin Prophylaxis Paste	Dentsply Intl.	1991	—
0 (this device)	K033449	Pro-Dentec Double-Pro Prophylaxis Paste with Fluoide Family of Devices	Professional Dental Technologies Therapeutics, Inc.	2004	—
+1	K040988	Zircon-F Prophylaxis Paste	Pascal Co., Inc.	2004	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0

FIG. 1 — Lineage of K033449, 1991–2004Source: 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
*	K912945	Satin Prophylaxis Paste Summary page 1 …2.6030) D. Product Code: EJR 5. Legally Marketed Predicate Device: NUPRO® Prophylaxis Paste with Fluoride made by Dentsply (K9 12945) 6. Description of the Device The Double-Pro TM Prophylaxis Paste with Fluoride family of devices, manu…	Dentsply Intl.	1991	—

Also cleared against K912945: 3 other devices →

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
K040988	Zircon-F Prophylaxis Paste	Pascal Co., Inc.	2004	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?

Its one ancestor has no recall.
Of its descendants, K040988 (Pascal Co., Inc., 2004) has gone furthest, with 0 descendants of its own.
3 other devices also cite its predicate K912945.

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	—	—

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.

https://510kreport.com/device/K033449 · printed Nov 6, 2026

Cite this page

510(k) Report. “K033449: Pro-Dentec Double-Pro Prophylaxis Paste with Fluoide Family of Devices.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033449

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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