Cleared Traditional

K162926 - Air-Powered Handpieces and Handpiece At...

K162926 is an FDA 510(k) clearance for Air-Powered Handpieces and Handpiece At..., manufactured by W&H Dentalwerk Burmoos GmbH. The device is a Class 1 Dental device with product code EFB cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K162926 · W&H Dentalwerk Burmoos GmbH · Dental device
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Feb 2017
Decision
127d
Days
Class 1
Risk

K162926 is an FDA 510(k) clearance for the Air-Powered Handpieces and Handpiece Attachments. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by W&H Dentalwerk Burmoos GmbH (Buermoos, AT). The FDA issued a Cleared decision on February 23, 2017 after a review of 127 days - within the typical 510(k) review window.

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 W&H Dentalwerk Burmoos GmbH devices

FDA 510(k) Submission Details - K162926

510(k) Number K162926 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 2016
Decision Date February 23, 2017
Days to Decision 127 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 127d · This submission: 127d
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 97
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