Cleared Traditional

SILVER CARE ANITBACTERIAL TOOTHBRUSH

K102871 · Piave Spazzolificio S.P.A. · Dental

Oct 2011

Decision

368d

Days

Class 1

Risk

About This 510(k) Submission

K102871 is an FDA 510(k) clearance for the SILVER CARE ANITBACTERIAL TOOTHBRUSH, a Toothbrush, Manual (Class I — General Controls, product code EFW), submitted by Piave Spazzolificio S.P.A. (New York, US). The FDA issued a Cleared decision on October 3, 2011, 368 days after receiving the submission on September 30, 2010. This device falls under the Dental review panel. Regulated under 21 CFR 872.6855.

Submission Details

510(k) Number	K102871 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 30, 2010
Decision Date	October 03, 2011
Days to Decision	368 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement