510(k) · Cleared
ClearedButler Gum Prophy Paste with Novamin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Usbiomaterials Corp. · EJR Agent, Polishing, Abrasive, Oral Cavity
Cleared on Jul 11, 2003 as substantially equivalent to K002989 (Ortek Therapeutics, Inc., 2000) after a 196-day review. Its family tree reaches back 1 generation to 2000. 17 later devices descend from it.
- Decided
- Jul 11, 2003
- Review
- 196 days
- Class
- Class I
- Product code
- EJR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K002989 (2000). 17 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK002989 ProcludeOrtek Therapeutics, Inc. · 2000
- This deviceK024343 Butler Gum Prophy Paste with NovaminUsbiomaterials Corp. · 2003
- Descendant · cites it directly · 7 of its ownK040858 Oralief Therapy for Sensitive TeethNovamin Technology, Inc. · 2004
- Descendant · cites it directly · 3 of its ownK041371 Butler Nucare Prophylaxis Paste with NovaminNovamin Technology, Inc. · 2004
- Descendant · cites it directly · 3 of its ownK040473 Oravive Tooth Revitalizing PasteNovamin Technology, Inc. · 2004
- Descendant · 2 generations on · 2 of its ownK120176 Senzzzzz AwayCentrix, Inc. · 2012
- Descendant · 2 generations on · 2 of its ownK103461 Colgate Desensitizing Dental CreamColgate-Palmolive Co. · 2011
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K040858Oralief Therapy for Sensitive TeethNovamin Technology, Inc. · 2004 · cites it directly7descendants
- K041371Butler Nucare Prophylaxis Paste with NovaminNovamin Technology, Inc. · 2004 · cites it directly3descendants
- K040473Oravive Tooth Revitalizing PasteNovamin Technology, Inc. · 2004 · cites it directly3descendants
- K120176Senzzzzz AwayCentrix, Inc. · 2012 · 2 generations on2descendants
- K103461Colgate Desensitizing Dental CreamColgate-Palmolive Co. · 2011 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002989 | Proclude | Ortek Therapeutics, Inc. | 2000 | — |
| 0 (this device) | K024343 | Butler Gum Prophy Paste with Novamin | Usbiomaterials Corp. | 2003 | — |
| +1 | K040858 | Oralief Therapy for Sensitive Teeth | Novamin Technology, Inc. | 2004 | — |
| +1 | K041371 | Butler Nucare Prophylaxis Paste with Novamin | Novamin Technology, Inc. | 2004 | — |
| +1 | K040473 | Oravive Tooth Revitalizing Paste | Novamin Technology, Inc. | 2004 | — |
| +2 | K120176 | Senzzzzz Away | Centrix, Inc. | 2012 | — |
| +2 | K103461 | Colgate Desensitizing Dental Cream | Colgate-Palmolive Co. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 4 | 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), 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? (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 | Decided |
|---|---|---|---|
| * | K002989 | ProcludeSummary page 2…physically occlude dentinal tubules in the same manner as the calcium carbonate/arginine complex in the predicate device, ProCludeO (K002989). Studies have concluded that NovaMinO is a non-irritant, and non-sensitizer, and is non-toxic. c JSBiom… | 2000 |
What descends from it? (17)
See all 175 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?
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?
Butler GU@' Prophylaxis Paste withNovaMinQ is intended for cleaning and polhhing
procedures as a part of a professionally administered dental prophylaxis treatment.
Sacondadly, Butler GUM@Prophylaxis Paste with NovaMinQ can be used for the
immediate relief of tooth sensitivity, post-scaling and root planing.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K024343 · printed Nov 3, 2026
Cite this page
510(k) Report. “K024343: Butler Gum Prophy Paste with Novamin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K024343
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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