510(k) · Cleared
ClearedOsspray Sylc CR
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osspray, Ltd. · EJR Agent, Polishing, Abrasive, Oral Cavity
Cleared on Mar 14, 2011 as substantially equivalent to K062502 (Ospray, Ltd., 2006) after a 144-day review. Its family tree reaches back 4 generations to 2000.
- Decided
- Mar 14, 2011
- Review
- 144 days
- Class
- Class I
- Product code
- EJR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K002989 (2000). No later device cites it as a predicate yet.
- Root · 4 generations backK002989 ProcludeOrtek Therapeutics, Inc. · 2000
- 3 generations backK024343 Butler Gum Prophy Paste with NovaminUsbiomaterials Corp. · 2003
- 2 generations backK041371 Butler Nucare Prophylaxis Paste with NovaminNovamin Technology, Inc. · 2004
- 1 generation backK062502 Osspray Cleaning CompoundOspray, Ltd. · 2006
- This deviceK103114 Osspray Sylc CROsspray, Ltd. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K002989 | Proclude | Ortek Therapeutics, Inc. | 2000 | — |
| −3 | K024343 | Butler Gum Prophy Paste with Novamin | Usbiomaterials Corp. | 2003 | — |
| −2 | K041371 | Butler Nucare Prophylaxis Paste with Novamin | Novamin Technology, Inc. | 2004 | — |
| −1 | K062502 | Osspray Cleaning Compound | Ospray, Ltd. | 2006 | — |
| 0 (this device) | K103114 | Osspray Sylc CR | Osspray, Ltd. | 2011 | — |
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 |
|---|---|---|---|
| * | K062502 | Osspray Cleaning CompoundSummary page 1…licate Classification Name: (FiR) Agent, Polishing, Abrasive, Oral Cavity 3. LEGALLY MARKETED PREDICATE DEVICE: Device Name: OSspray Cleaning Compound 5 10(k) Number: K062502 Applicant: OiSspray Ltd, Hodgkin Building, King's College London, Guys Hospital Campus, London, SF1I IUL 4. DEVICE DESCRIPTION:… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
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 11 years and passes through 5 companies; a new generation was cleared every 2.6 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K062502.
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. 2011, this device’s year, is highlighted.
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?
OSspray Sylc. CR compound is a single-phase calcium phosphosilicate ceramic product intended for the removal of weakened or decayed small enamel lesions, in addition to the cleaning of enamel surfaces and providing relief of hypersensitivity associated with exposed dentin and open dentinal tubules.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103114 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103114: Osspray Sylc CR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103114
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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