510(k) · Cleared
ClearedSatin Prophylaxis Paste
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentsply Intl. · EJR Agent, Polishing, Abrasive, Oral Cavity
Cleared on Sep 16, 1991 after a 73-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 6 later devices descend from it.
- Decided
- Sep 16, 1991
- Review
- 73 days
- Class
- Class I
- Product code
- EJR
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 4 citing it directly.
- This deviceK912945 Satin Prophylaxis PasteDentsply Intl. · 1991
- Descendant · cites it directly · 1 of its ownK033449 Pro-Dentec Double-Pro Prophylaxis Paste with Fluoide Family of DevicesProfessional Dental Technologies Therapeutics, Inc. · 2004
- Descendant · cites it directly · 1 of its ownK983966 Nupro Prophylaxis Paste with Flouride and TriclosanDentsply Intl. · 1999
- Descendant · cites it directly · 0 of its ownK102053 Butler Calci-Flor Prophylaxis PasteSunstar Americas, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK100539 Preventech Prophylaxis Paste with FluoridePreventive Technologies, Inc. · 2010
- Descendant · 2 generations on · 0 of its ownK061427 Pre-Impression Conditioning SolutionDentsply Intl. · 2006
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K033449Pro-Dentec Double-Pro Prophylaxis Paste with Fluoide Family of DevicesProfessional Dental Technologies Therapeutics, Inc. · 2004 · cites it directly1descendant
- K983966Nupro Prophylaxis Paste with Flouride and TriclosanDentsply Intl. · 1999 · cites it directly1descendant
- K102053Butler Calci-Flor Prophylaxis PasteSunstar Americas, Inc. · 2011 · cites it directly0descendants
- K100539Preventech Prophylaxis Paste with FluoridePreventive Technologies, Inc. · 2010 · cites it directly0descendants
- K061427Pre-Impression Conditioning SolutionDentsply Intl. · 2006 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K912945 | Satin Prophylaxis Paste | Dentsply Intl. | 1991 | — |
| +1 | K033449 | Pro-Dentec Double-Pro Prophylaxis Paste with Fluoide Family of Devices | Professional Dental Technologies Therapeutics, Inc. | 2004 | — |
| +1 | K983966 | Nupro Prophylaxis Paste with Flouride and Triclosan | Dentsply Intl. | 1999 | — |
| +1 | K102053 | Butler Calci-Flor Prophylaxis Paste | Sunstar Americas, Inc. | 2011 | — |
| +1 | K100539 | Preventech Prophylaxis Paste with Fluoride | Preventive Technologies, Inc. | 2010 | — |
| +2 | K061427 | Pre-Impression Conditioning Solution | Dentsply Intl. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (6)
4 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, K033449 (Professional Dental Technologies Therapeutics, Inc., 2004) has gone furthest, with 1 descendant 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/K912945 · printed Nov 4, 2026
Cite this page
510(k) Report. “K912945: Satin Prophylaxis Paste.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K912945
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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