Cleared Traditional

K060287 - DRILLTECH, ISM, IMPLANTUNIT, ZIMMER SURGICAL MOTOR SYSTEM

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 128d · 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 59
Devices cleared under the same product code (EBW) and FDA review panel - the closest regulatory comparables to K060287.
IMM DENTAL IRRIGATION TUBING SET
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E-STATIS 40 SYSTEM
K090937 · Scican , Ltd. · Jul 2009
NUTORQUE PROGRAMMABLE ELECTRIC SYSTEM
K083252 · Dentalez Group, Stardental Division · Feb 2009
IMPLANTMED SI-915 (115V VERSION)
K052741 · W&H Dentalwerk Buermoos GmbH · Jan 2006
IRRIGATION TUBING SET 2.2M AND 3.8M
K041124 · W&H Dentalwerk Burmoos · Jun 2004
A-DEC/W&H ELECTRIC MOTOR, MODEL EA-50LT
K032572 · A-Dec, Inc. · Dec 2003