Cleared Traditional

K102871 - SILVER CARE ANITBACTERIAL TOOTHBRUSH

K102871 is an FDA 510(k) clearance for SILVER CARE ANITBACTERIAL TOOTHBRUSH, manufactured by Piave Spazzolificio S.P.A.. The device is a Class 1 Dental device with product code EFW cleared through the Traditional 510(k) pathway after a 368-day FDA review.

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.

FDA 510(k) Submission Details - K102871

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
240d slower than avg
Panel avg: 128d · This submission: 368d
Pathway characteristics
Predicate-based equivalence.

EFW Device Classification - Class 1, General Controls

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.

Regulatory Peers - EFW Toothbrush, Manual

All 29
Devices cleared under the same product code (EFW) and FDA review panel - the closest regulatory comparables to K102871.
DENTEK EASY BRUSH WITH FLUORIDE
K130186 · Den Tek Oral Care, Inc. · Jul 2013
BEAM BRUSH/BEAM APP
K121165 · Beam Technologies, LLC · Jun 2012
ORAL-B SUB-BRAND MANUAL TOOTHBRUSH
K073224 · Procter & Gamble · Feb 2008
ZEODYNE TOOTHBRUSH WITH AGION ANTIMICROBIAL
K021383 · Agion Technologies, LLC · Jul 2002
MEDORAL HYGIENIC TOOTHBRUSH WITH DENTOSAN FILAMENTS
K020776 · Coronet Group North America, LLC · Jun 2002
LAZERSMILE, LAZERWHITE
K000290 · Biolase Technology, Inc. · Apr 2000
K102871 · SILVER CARE ANITBACTERIAL TOOTHBRUSH
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