510(k) · Cleared
Recalled · Class II · 2015Silver Care Anitbacterial Toothbrush
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Piave Spazzolificio S.P.A. · EFW Toothbrush, Manual
Cleared on Oct 3, 2011 after a 368-day review. FDA’s file for it is a 510(k) statement, which names no predicate. It has been recalled once.
- Decided
- Oct 3, 2011
- Review
- 368 days
- Class
- Class I
- Product code
- EFW
- Recalls
- 1
- 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 EFW? 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 3, 2015 | Class II | Z-1213-2015 | Under Investigation by firm | The toothbrush head can potentially disengage from the handle. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All EFW devicesEFW Toothbrush, Manual: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · EFW
1in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · EFW
Too few EFW 510(k)s in any year since 2007 to give a median.
Recalls per year · EFW
No recall names EFW since 2007.
Adverse event reports per year · EFW
71in 2025
MAUDE reports naming product code EFW, 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 | 0 | — | 0 | 6 |
| 2008 | 1 | — | 0 | 10 |
| 2009 | 0 | — | 0 | 9 |
| 2010 | 0 | — | 0 | 2 |
| 2011 | 1 | — | 0 | 13 |
| 2012 | 1 | — | 0 | 145 |
| 2013 | 1 | — | 0 | 60 |
| 2014 | 0 | — | 0 | 23 |
| 2015 | 0 | — | 0 | 48 |
| 2016 | 0 | — | 0 | 35 |
| 2017 | 0 | — | 0 | 68 |
| 2018 | 0 | — | 0 | 109 |
| 2019 | 0 | — | 0 | 115 |
| 2020 | 0 | — | 0 | 113 |
| 2021 | 0 | — | 0 | 120 |
| 2022 | 0 | — | 0 | 327 |
| 2023 | 0 | — | 0 | 99 |
| 2024 | 0 | — | 0 | 87 |
| 2025 | 0 | — | 0 | 71 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Silver Care Antibacterial Toothbrush is intended for over-the-counter use as a toothbrush. The antibacterial agent maintains the cleanliness of the brush by preventing the growth of bacteria on and between the filaments after use. The Silver Care is effective against E. coli (ATCC 25922), Kiebsiella pneumoniae (ATCC 13388), Streptococcus mutans (ATCC 35668), and Pseudomonas aerugmnosa (ATCC 27853) at 24 hours of exposure under moist conditions.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K102871 · printed Nov 4, 2026
Cite this page
510(k) Report. “K102871: Silver Care Anitbacterial Toothbrush.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K102871
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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