510(k) · Cleared
ClearedProclude
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortek Therapeutics, Inc. · EJR Agent, Polishing, Abrasive, Oral Cavity
Cleared on Dec 14, 2000 after an 80-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 19 later devices descend from it.
- Decided
- Dec 14, 2000
- Review
- 80 days
- Class
- Class I
- Product code
- EJR
- Recalls
- None
- Predicates
- 0
19 later devices descend from it, 3 citing it directly.
- This deviceK002989 ProcludeOrtek Therapeutics, Inc. · 2000
- Descendant · cites it directly · 17 of its ownK024343 Butler Gum Prophy Paste with NovaminUsbiomaterials Corp. · 2003
- Descendant · 2 generations on · 7 of its ownK040858 Oralief Therapy for Sensitive TeethNovamin Technology, Inc. · 2004
- Descendant · 2 generations on · 3 of its ownK041371 Butler Nucare Prophylaxis Paste with NovaminNovamin Technology, Inc. · 2004
- Descendant · 2 generations on · 3 of its ownK040473 Oravive Tooth Revitalizing PasteNovamin Technology, Inc. · 2004
- Descendant · 3 generations on · 2 of its ownK120176 Senzzzzz AwayCentrix, Inc. · 2012
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K024343Butler Gum Prophy Paste with NovaminUsbiomaterials Corp. · 2003 · cites it directly17descendants
- K040858Oralief Therapy for Sensitive TeethNovamin Technology, Inc. · 2004 · 2 generations on7descendants
- K041371Butler Nucare Prophylaxis Paste with NovaminNovamin Technology, Inc. · 2004 · 2 generations on3descendants
- K040473Oravive Tooth Revitalizing PasteNovamin Technology, Inc. · 2004 · 2 generations on3descendants
- K120176Senzzzzz AwayCentrix, Inc. · 2012 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002989 | Proclude | Ortek Therapeutics, Inc. | 2000 | — |
| +1 | K024343 | Butler Gum Prophy Paste with Novamin | Usbiomaterials Corp. | 2003 | — |
| +2 | K040858 | Oralief Therapy for Sensitive Teeth | Novamin Technology, Inc. | 2004 | — |
| +2 | K041371 | Butler Nucare Prophylaxis Paste with Novamin | Novamin Technology, Inc. | 2004 | — |
| +2 | K040473 | Oravive Tooth Revitalizing Paste | Novamin Technology, Inc. | 2004 | — |
| +3 | K120176 | Senzzzzz Away | Centrix, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 5 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2022 | 1 | 0 |
| 2026 | 1 | 0 |
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
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? (19)
See all 193 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K024343 (Usbiomaterials Corp., 2003) has gone furthest, with 17 descendants of its own.
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 | — |
https://510kreport.com/device/K002989 · printed Nov 4, 2026
Cite this page
510(k) Report. “K002989: Proclude.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K002989
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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