Cleared Traditional

K060287 - DRILLTECH

K060287 is an FDA 510(k) clearance for DRILLTECH, 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 86-day FDA review.

K060287 · W&H Dentalwerk Buermoos GmbH · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2006
Decision
86d
Days
Class 1
Risk

K060287 is an FDA 510(k) clearance for the DRILLTECH, ISM, IMPLANTUNIT, ZIMMER SURGICAL MOTOR SYSTEM. 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, 2006 after a review of 86 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 W&H Dentalwerk Buermoos GmbH devices

FDA 510(k) Submission Details - K060287

510(k) Number K060287 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 2006
Decision Date May 03, 2006
Days to Decision 86 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
41d faster than avg
Panel avg: 127d · This submission: 86d
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 K060287.
XSmart iQ
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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