Cleared Traditional

SILVER CARE ANITBACTERIAL TOOTHBRUSH (K102871) - FDA 510(k) Clearance

Class I Dental device.

K102871 · Piave Spazzolificio S.P.A. · Dental device
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Oct 2011
Decision
368d
Days
Class 1
Risk

K102871 is an FDA 510(k) clearance for the SILVER CARE ANITBACTERIAL TOOTHBRUSH. Classified as Toothbrush, Manual (product code EFW), Class I - General Controls.

Submitted by Piave Spazzolificio S.P.A. (New York, US). The FDA issued a Cleared decision on October 3, 2011 after a review of 368 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6855 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Piave Spazzolificio S.P.A. devices

Submission Details

510(k) Number K102871 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
241d slower than avg
Panel avg: 127d · This submission: 368d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EFW Toothbrush, Manual
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6855
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.