# K102871: Silver Care Anitbacterial Toothbrush

- Pathway: 510(k) (Traditional)
- Applicant: Piave Spazzolificio S.P.A.
- Decided: Oct 3, 2011 after 368 days
- Product code: EFW (Toothbrush, Manual)
- Device class: 1
- Regulation: 21 CFR 872.6855
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Feb 3, 2015 · Class II · Z-1213-2015: The toothbrush head can potentially disengage from the handle.

## Indications for use
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.

Source page: https://510kreport.com/device/K102871
Methodology: https://510kreport.com/methodology