Cleared Traditional

K090727 - IMM DENTAL IRRIGATION TUBING SET

K090727 is an FDA 510(k) clearance for IMM DENTAL IRRIGATION TUBING SET, manufactured by Innovative Medical Manufacturing Co.. The device is a Class 1 Dental device with product code EBW cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K090727 · Innovative Medical Manufacturing Co. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2009
Decision
147d
Days
Class 1
Risk

K090727 is an FDA 510(k) clearance for the IMM DENTAL IRRIGATION TUBING SET. Classified as Controller, Foot, Handpiece And Cord (product code EBW), Class I - General Controls.

Submitted by Innovative Medical Manufacturing Co. (Houston, US). The FDA issued a Cleared decision on August 13, 2009 after a review of 147 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 Innovative Medical Manufacturing Co. devices

FDA 510(k) Submission Details - K090727

510(k) Number K090727 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 2009
Decision Date August 13, 2009
Days to Decision 147 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
20d slower than avg
Panel avg: 127d · This submission: 147d
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 38
Devices cleared under the same product code (EBW) and FDA review panel - the closest regulatory comparables to K090727.
A-DEC/W&H ELECTRIC HANDPIECE MOTOR
K133776 · A-Dec, Inc. · May 2014
E3 TORQUE CONTROL MOTOR
K103653 · Dentsply International, Inc. · May 2011
X-CUBE
K092758 · Saeshin Precision Co., Ltd. · Sep 2009
DRILLTECH, ISM, IMPLANTUNIT, ZIMMER SURGICAL MOTOR SYSTEM
K060287 · W&H Dentalwerk Buermoos GmbH · May 2006
IMPLANTMED SI-915 (115V VERSION)
K052741 · W&H Dentalwerk Buermoos GmbH · Jan 2006
A-DEC/W&H ELECTRIC MOTOR, MODEL EA-50LT
K032572 · A-Dec, Inc. · Dec 2003