Cleared Special

K133776 - A-DEC/W&H ELECTRIC HANDPIECE MOTOR

K133776 is the FDA 510(k) clearance for A-DEC/W&H ELECTRIC HANDPIECE MOTOR by A-Dec, Inc.. It is a Class 1 Dental device (product code EBW) cleared through the Special 510(k) pathway after a 167-day FDA review.

K133776 · A-Dec, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2014
Decision
167d
Days
Class 1
Risk

K133776 is an FDA 510(k) clearance for the A-DEC/W&H ELECTRIC HANDPIECE MOTOR. Classified as Controller, Foot, Handpiece And Cord (product code EBW), Class I - General Controls.

Submitted by A-Dec, Inc. (Newberg, US). The FDA issued a Cleared decision on May 28, 2014 after a review of 167 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all A-Dec, Inc. devices

Submission Details

510(k) Number K133776 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 2013
Decision Date May 28, 2014
Days to Decision 167 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d slower than avg
Panel avg: 127d · This submission: 167d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code EBW Controller, Foot, Handpiece And Cord
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 - EBW Controller, Foot, Handpiece And Cord

All 30
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