510(k) · Cleared
ClearedOsspray Cleaning Compound
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ospray, Ltd. · EJR Agent, Polishing, Abrasive, Oral Cavity
Cleared on Dec 15, 2006 as substantially equivalent to K041371 (Novamin Technology, Inc., 2004) after a 112-day review. Its family tree reaches back 3 generations to 2000. 2 later devices descend from it.
- Decided
- Dec 15, 2006
- Review
- 112 days
- Class
- Class I
- Product code
- EJR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K002989 (2000). 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK002989 ProcludeOrtek Therapeutics, Inc. · 2000
- 2 generations backK024343 Butler Gum Prophy Paste with NovaminUsbiomaterials Corp. · 2003
- 1 generation backK041371 Butler Nucare Prophylaxis Paste with NovaminNovamin Technology, Inc. · 2004
- This deviceK062502 Osspray Cleaning CompoundOspray, Ltd. · 2006
- Descendant · cites it directly · 0 of its ownK103114 Osspray Sylc CROsspray, Ltd. · 2011
- Descendant · cites it directly · 0 of its ownK100833 Syle SmartipOsspray, Ltd. · 2010
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K002989 | Proclude | Ortek Therapeutics, Inc. | 2000 | — |
| −2 | K024343 | Butler Gum Prophy Paste with Novamin | Usbiomaterials Corp. | 2003 | — |
| −1 | K041371 | Butler Nucare Prophylaxis Paste with Novamin | Novamin Technology, Inc. | 2004 | — |
| 0 (this device) | K062502 | Osspray Cleaning Compound | Ospray, Ltd. | 2006 | — |
| +1 | K103114 | Osspray Sylc CR | Osspray, Ltd. | 2011 | — |
| +1 | K100833 | Syle Smartip | Osspray, Ltd. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K041371 | Butler Nucare Prophylaxis Paste with NovaminSummary page 1…Name: Prophy Powder 510(k) Number: Exempt Applicant: PAC-Dent INTL. Inc (Owner Number 9029860) Device Name: BUTLER NUCARE PROPHYLAXIS PASTE WITH NOVAMIN 510(k) Number: K041371 Applicant: NOVAMIN TECHNOLOGY, INC., 13709 Progress Blvd., Suite. 23, Alachua, FL 32615 4. DEVICE DESCRIPTION: The OSspray Clea… | 2004 |
| * | — | Prophy Powder Named without a submission number |
What descends from it? (2)
2 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?
- The line of descent spans 6 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K103114 (Osspray, Ltd., 2011) has gone furthest, with 0 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 | — |
What is it indicated for?
The OSspray Cleaning Compound is intended for cleaning and polishing procedures as part of a professionally administered dental prophylaxis treatment. The OSspray Cleaning Compound is also intended to provide relief from tooth sensitivity during the prophylaxis treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062502 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062502: Osspray Cleaning Compound.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062502
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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