510(k) · Cleared
ClearedEnamel Pro
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Premier Dental Products Co. · EJR Agent, Polishing, Abrasive, Oral Cavity
Cleared on Nov 21, 2006 after a 116-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 later devices descend from it.
- Decided
- Nov 21, 2006
- Review
- 116 days
- Class
- Class I
- Product code
- EJR
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK062166 Enamel ProPremier Dental Products Co. · 2006
- 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
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 |
|---|---|---|---|---|---|
| 0 (this device) | K062166 | Enamel Pro | Premier Dental Products Co. | 2006 | — |
| +1 | K102053 | Butler Calci-Flor Prophylaxis Paste | Sunstar Americas, Inc. | 2011 | — |
| +1 | K100539 | Preventech Prophylaxis Paste with Fluoride | Preventive Technologies, Inc. | 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 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? (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?
- Of its descendants, K102053 (Sunstar Americas, Inc., 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?
To be used for cleaning and polishing procedures as part of a professionally administered prophylaxis treatment.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K062166 · printed Nov 5, 2026
Cite this page
510(k) Report. “K062166: Enamel Pro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K062166
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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