510(k) · Cleared
ClearedProactive Care Prophylaxis Paste with Fluoride
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Discus Dental, Inc. · EJR Agent, Polishing, Abrasive, Oral Cavity
Cleared on Jun 18, 2004 as substantially equivalent to K000169 (Dentsply Intl., 2000) and 2 other predicates after a 197-day review. Its family tree reaches back 1 generation to 1999.
- Decided
- Jun 18, 2004
- Review
- 197 days
- Class
- Class I
- Product code
- EJR
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K990482 (1999). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK990482 3M Clinpro Prophy Paste, Model 12611Minnesota Mining and Mfg. Co. · 1999
- This deviceK033785 Proactive Care Prophylaxis Paste with FluorideDiscus Dental, Inc. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K990482 | 3M Clinpro Prophy Paste, Model 12611 | Minnesota Mining and Mfg. Co. | 1999 | — |
| 0 (this device) | K033785 | Proactive Care Prophylaxis Paste with Fluoride | Discus Dental, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
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
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K000169 | Nupro Prophylaxis Paste with Fluoride and TriclosanSummary page 2…ce Determination The ProActive Carem Prophylaxis Paste is substantially equivalent to the following products: a) Nupro® T Prophylaxis Paste with Fluoride and Triclosan ( K000169) b) ProClude® (K002989) ¢) 3M™ Clinpro™ Prophy Paste (K990482) 5 8550 Higuera Street - Culver City, CA 90232 - www.discusdenta… | 2000 |
| * | K002989 | ProcludeSummary page 2…oActive Carem Prophylaxis Paste is substantially equivalent to the following products: a) Nupro® T Prophylaxis Paste with Fluoride and Triclosan ( K000169) b) ProClude® (K002989) ¢) 3M™ Clinpro™ Prophy Paste (K990482) 5 8550 Higuera Street - Culver City, CA 90232 - www.discusdental.com - Tel. 310.845.82… | 2000 |
| * | K990482 | 3M Clinpro Prophy Paste, Model 12611Summary page 2…antially equivalent to the following products: a) Nupro® T Prophylaxis Paste with Fluoride and Triclosan ( K000169) b) ProClude® (K002989) ¢) 3M™ Clinpro™ Prophy Paste (K990482) 5 8550 Higuera Street - Culver City, CA 90232 - www.discusdental.com - Tel. 310.845.8200 - Fax 310.845.1537 DE… | 1999 |
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?
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K000169.
How does its category compare?
All EJR devicesEJR Agent, Polishing, Abrasive, Oral Cavity: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EJR
1in 2017
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
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 | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 6 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 2 | — | 0 | 3 |
| 2011 | 2 | — | 0 | 1 |
| 2012 | 1 | — | 0 | 3 |
| 2013 | 0 | — | 0 | 9 |
| 2014 | 1 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 10 |
| 2016 | 0 | — | 0 | 9 |
| 2017 | 1 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 8 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 6 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 4 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
To be used for cleaning and polishing procedures as part of a professionally administered prophylaxis treatment.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K033785 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033785: Proactive Care Prophylaxis Paste with Fluoride.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033785
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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