Cleared Abbreviated

K090548 - CONTRA-ANGLE HANDPIECE KOMET OS30

K090548 is an FDA 510(k) clearance for CONTRA-ANGLE HANDPIECE KOMET OS30, manufactured by W&H Dentalwerk Buermoos GmbH. The device is a Class 1 Dental device with product code EFB cleared through the Abbreviated 510(k) pathway after a 120-day FDA review.

K090548 · W&H Dentalwerk Buermoos GmbH · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2009
Decision
120d
Days
Class 1
Risk

K090548 is an FDA 510(k) clearance for the CONTRA-ANGLE HANDPIECE KOMET OS30. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by W&H Dentalwerk Buermoos GmbH (Buermoos, AT). The FDA issued a Cleared decision on June 30, 2009 after a review of 120 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all W&H Dentalwerk Buermoos GmbH devices

FDA 510(k) Submission Details - K090548

510(k) Number K090548 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2009
Decision Date June 30, 2009
Days to Decision 120 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 127d · This submission: 120d
Pathway characteristics
Standards-based clearance path.

EFB Device Classification - Class 1, General Controls

Product Code EFB Handpiece, Air-powered, Dental
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 - EFB Handpiece, Air-powered, Dental

All 91
Devices cleared under the same product code (EFB) and FDA review panel - the closest regulatory comparables to K090548.
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K081811 · Nakanishi, Inc. · Jan 2009
A-DEC/W&H ALEGRA AIR-DRIVEN HIGHSPEED HANDPIECE, MODEL TE-97, TE-98, A-DEC/W&H ALEGRA HANDPIECE ATTACHMENT, MODEL HE-43
K082716 · A-Dec, Inc. · Jan 2009