Cleared Traditional

K905071 - MX CYCLER

K905071 is an FDA 510(k) clearance for MX CYCLER, manufactured by Dakmed, Inc.. The device is a Class 1 Dental device with product code EKX cleared through the Traditional 510(k) pathway after a 200-day FDA review.

K905071 · Dakmed, Inc. · Dental device
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May 1991
Decision
200d
Days
Class 1
Risk

K905071 is an FDA 510(k) clearance for the MX CYCLER. Classified as Handpiece, Direct Drive, Ac-powered (product code EKX), Class I - General Controls.

Submitted by Dakmed, Inc. (Buffalo, US). The FDA issued a Cleared decision on May 28, 1991 after a review of 200 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 Dakmed, Inc. devices

FDA 510(k) Submission Details - K905071

510(k) Number K905071 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1990
Decision Date May 28, 1991
Days to Decision 200 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d slower than avg
Panel avg: 127d · This submission: 200d
Pathway characteristics
Predicate-based equivalence.

EKX Device Classification - Class 1, General Controls

Product Code EKX Handpiece, Direct Drive, Ac-powered
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 - EKX Handpiece, Direct Drive, Ac-powered

All 79
Devices cleared under the same product code (EKX) and FDA review panel - the closest regulatory comparables to K905071.
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PERIOTEST
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