Cleared Traditional

K101612 - ZEN CORDLESS PROPHY SYSTEM

K101612 is an FDA 510(k) clearance for ZEN CORDLESS PROPHY SYSTEM, manufactured by Discus Dental, LLC. The device is a Class 1 Dental device with product code EKX cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K101612 · Discus Dental, LLC · Dental device
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Jun 2010
Decision
21d
Days
Class 1
Risk

K101612 is an FDA 510(k) clearance for the ZEN CORDLESS PROPHY SYSTEM. Classified as Handpiece, Direct Drive, Ac-powered (product code EKX), Class I - General Controls.

Submitted by Discus Dental, LLC (Culver City, US). The FDA issued a Cleared decision on June 30, 2010 after a review of 21 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Discus Dental, LLC devices

FDA 510(k) Submission Details - K101612

510(k) Number K101612 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 2010
Decision Date June 30, 2010
Days to Decision 21 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
106d faster than avg
Panel avg: 127d · This submission: 21d
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

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 57
Devices cleared under the same product code (EKX) and FDA review panel - the closest regulatory comparables to K101612.
MIDWEST RDH FREEDOM CORDLESS PROPHY SYSTEM
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PROSTHODONTIC SCREWDRIVER , MODEL IA-400
K100600 · W&H Dentalwerk Buermoos GmbH · Jul 2010
CORDLESS ENDO HANDPIECES EB-300, ENTRAN AND EB-300 S, S5 ENDO MOTOR
K090931 · W&H Dentalwerk Buermoos GmbH · Dec 2009
ROOT ZX II
K071190 · J. Morita USA, Inc. · Aug 2007
SIROENDO
K052515 · Sirona Dental Systems GmbH · Mar 2006