SILVER CARE ANITBACTERIAL TOOTHBRUSH— 510(k) K102871

Name: FDA 510(k) clearance K102871
Creator: U.S. Food and Drug Administration
Published: 2011-10-03

Substantially Equivalent

Piave Spazzolificio S.P.A.

FDA 510(k) clearance K102871 for SILVER CARE ANITBACTERIAL TOOTHBRUSH, Substantially Equivalent on 2011-10-03. Applicant: Piave Spazzolificio S.P.A.. Device class: 1.

Clearance details

Applicant: Piave Spazzolificio S.P.A.
Product code: Code EFW
Device class: Class 1
Regulation: 21 CFR 872.6855
Advisory panel: Dental
Date received: 2010-09-30
Decision date: 2011-10-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EFW

view all

K130186 — DENTEK EASY BRUSH WITH FLUORIDE2013-07-15
K121165 — BEAM BRUSH/BEAM APP2012-06-21
K073224 — ORAL-B SUB-BRAND MANUAL TOOTHBRUSH2008-02-06
K021383 — ZEODYNE TOOTHBRUSH WITH AGION ANTIMICROBIAL2002-07-17
K020776 — MEDORAL HYGIENIC TOOTHBRUSH WITH DENTOSAN FILAMENTS2002-06-03

Adverse events under product code EFW

product code EFW

Injury: 143
Malfunction: 698
Total: 841

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K102871

K-number listed on FDA's recall record

Z-1213-2015 — Manual Toothbrush; SilverCare Junior 2/6 years Antibacterial Toothbrush Made in Italy The product is intended for over the counter use as a toothbrush. The silver plating is an antimicrobial agent which maintains the cleanliness of the brush by preventing growth of bacteria on and between the filaments after use.Class II·Terminated·Norwex Usa Inc·20150203

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K102871.

Data sourced from openFDA. This site is unofficial and independent of the FDA.