Cleared Traditional

K014068 - ELCOMED

K014068 is an FDA 510(k) clearance for ELCOMED, manufactured by W&H Dentalwerk Buermoos GmbH. The device is a Class 1 Dental device with product code EBW cleared through the Traditional 510(k) pathway after a 144-day FDA review.

K014068 · W&H Dentalwerk Buermoos GmbH · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2002
Decision
144d
Days
Class 1
Risk

K014068 is an FDA 510(k) clearance for the ELCOMED, MODELS SA-200 C 230, SA-200 230, SA-200 C 115, SA-200 115. Classified as Controller, Foot, Handpiece And Cord (product code EBW), Class I - General Controls.

Submitted by W&H Dentalwerk Buermoos GmbH (Buermoos, AT). The FDA issued a Cleared decision on May 3, 2002 after a review of 144 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 Buermoos GmbH devices

FDA 510(k) Submission Details - K014068

510(k) Number K014068 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 2001
Decision Date May 03, 2002
Days to Decision 144 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
17d slower than avg
Panel avg: 127d · This submission: 144d
Pathway characteristics
Predicate-based equivalence.

EBW Device Classification - Class 1, General Controls

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 32
Devices cleared under the same product code (EBW) and FDA review panel - the closest regulatory comparables to K014068.
E3 TORQUE CONTROL MOTOR
K103653 · Dentsply International, Inc. · May 2011
A-DEC/W&H ELECTRIC MOTOR, MODEL EA-50LT
K032572 · A-Dec, Inc. · Dec 2003
SIROTORQUE L
K031584 · Sirona Dental Systems GmbH · Aug 2003
SURGIC IV IMPLANT CONTROL UNIT
K020327 · Nakanishi, Inc. · Apr 2002
ELEC-MATE E
K011926 · Nakanishi, Inc. · Sep 2001
ROTARY MASTER
K992648 · J. Morita USA, Inc. · Jan 2000