510(k) · Cleared
ClearedButler Nucare Prophylaxis Paste with Novamin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Novamin Technology, Inc. · EJR Agent, Polishing, Abrasive, Oral Cavity
Cleared on Aug 23, 2004 as substantially equivalent to K024343 (Usbiomaterials Corp., 2003) after a 91-day review. Its family tree reaches back 2 generations to 2000. 3 later devices descend from it.
- Decided
- Aug 23, 2004
- Review
- 91 days
- Class
- Class I
- Product code
- EJR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K002989 (2000). 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK002989 ProcludeOrtek Therapeutics, Inc. · 2000
- 1 generation backK024343 Butler Gum Prophy Paste with NovaminUsbiomaterials Corp. · 2003
- This deviceK041371 Butler Nucare Prophylaxis Paste with NovaminNovamin Technology, Inc. · 2004
- Descendant · cites it directly · 2 of its ownK062502 Osspray Cleaning CompoundOspray, Ltd. · 2006
- Descendant · 2 generations on · 0 of its ownK103114 Osspray Sylc CROsspray, Ltd. · 2011
- Descendant · 2 generations on · 0 of its ownK100833 Syle SmartipOsspray, Ltd. · 2010
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K002989 | Proclude | Ortek Therapeutics, Inc. | 2000 | — |
| −1 | K024343 | Butler Gum Prophy Paste with Novamin | Usbiomaterials Corp. | 2003 | — |
| 0 (this device) | K041371 | Butler Nucare Prophylaxis Paste with Novamin | Novamin Technology, Inc. | 2004 | — |
| +1 | K062502 | Osspray Cleaning Compound | Ospray, Ltd. | 2006 | — |
| +2 | K103114 | Osspray Sylc CR | Osspray, Ltd. | 2011 | — |
| +2 | K100833 | Syle Smartip | Osspray, Ltd. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 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 |
|---|---|---|---|
| * | K024343 | Butler Gum Prophy Paste with NovaminSummary page 1…phylaxis Paste 3. LEGALLY MARKETED PREDICATE DEVICE: Device Name: Butler GUM®'Prophylaxis Paste with NovaMiny® 5 10(k) Number: K024343 Applicant: NovaMin Technology, Inc. 4. DEVICE DESCRIPTION: Butler NuCareTM Prophylaxis Paste… | 2003 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062502 | Osspray Cleaning Compound | 2006 | 2 |
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?
- The line of descent spans 4 years and passes through 3 companies; a new generation was cleared every 2.6 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K062502 (Ospray, Ltd., 2006) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K024343.
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 NuCare Prophylaxis Paste with NovaMin is intended for cleaning and polishing procedures as part of a professionally administered dental prophylaxis treatment. Secondarily, Butler NuCare Prophylaxis Paste with NovaMin can be used for the immediate relief of sensitivity, post-sealing and root planing.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041371 · printed Nov 4, 2026
Cite this page
510(k) Report. “K041371: Butler Nucare Prophylaxis Paste with Novamin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K041371
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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