Cleared Traditional

K160410 - WOlf High Speed Handpieces - Medium head

K160410 is an FDA 510(k) clearance for WOlf High Speed Handpieces - Medium head, manufactured by Dental Savings Club. The device is a Class 1 Dental device with product code EFB cleared through the Traditional 510(k) pathway after a 226-day FDA review.

K160410 · Dental Savings Club · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2016
Decision
226d
Days
Class 1
Risk

K160410 is an FDA 510(k) clearance for the WOlf High Speed Handpieces - Medium head, WOlf High Speed Handpieces - Small .... Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by Dental Savings Club (Montreal, CA). The FDA issued a Cleared decision on September 29, 2016 after a review of 226 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4200 - 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. Standard predicate reliance. 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 Dental Savings Club devices

FDA 510(k) Submission Details - K160410

510(k) Number K160410 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 2016
Decision Date September 29, 2016
Days to Decision 226 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
99d slower than avg
Panel avg: 127d · This submission: 226d
Pathway characteristics
Predicate-based equivalence.

EFB Device Classification - Class 1, General Controls

Product Code EFB Handpiece, Air-powered, Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4200
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 - EFB Handpiece, Air-powered, Dental

All 98
Devices cleared under the same product code (EFB) and FDA review panel - the closest regulatory comparables to K160410.
PERIO-FLOW nozzle
K171174 · E.M.S Electro Medical Systems S.A · Dec 2017
W&H Assistina Twin
K171553 · W&H Dentalwerk Buermoos GmbH · Dec 2017
PANA SPRAY Plus
K163483 · Nakanishi, Inc. · Aug 2017
AIR-FLOW handy 3.0 PLUS
K151912 · E.M.S Electro Medical Systems S.A · Feb 2016
Advanced Air System
K143704 · W&H Dentalwerk Buermoos GmbH · Nov 2015
T1/T2/T3 TURBINE FAMILY
K131319 · Sirona Dental Systems GmbH · May 2014