Cleared Traditional

K160410 - WOlf High Speed Handpieces - Medium head, WOlf High Speed Handpieces - Small 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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
98d slower than avg
Panel avg: 128d · 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 Consultant

Qualmed Corporation
Gordon Wehner

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - EFB Handpiece, Air-powered, Dental

All 222
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