510(k) · Cleared
ClearedGelato Prophylaxis Paste
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Deepak Products, Inc. · EJR Agent, Polishing, Abrasive, Oral Cavity
Cleared on Oct 26, 2004 after an 88-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Oct 26, 2004
- Review
- 88 days
- Class
- Class I
- Product code
- EJR
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
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?
For cleaning and polishing procedures as part of a professionally administered prophylaxis treatment. NOTE: Prophylasis pastes containing fluoride are not considered a replacement for other forms of fluoride therapy.
Gelato dental prophylaxis paste with fluoride contains a unique blend of polishing and cleaning agents. Dental Prophylaxis Paste is for professional use only and is designed for application during standard dental practice hygiene procedures.
This product contains fluoride at a concentration of 1.23% fluoride ion.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K042048 · printed Nov 5, 2026
Cite this page
510(k) Report. “K042048: Gelato Prophylaxis Paste.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042048
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026