Cleared Traditional

K100389 - HHC PUSH-BUTTON REPLACEMENT TURBINE FOR MIDWEST TRADITION HANDPIECE MODEL MW TURBINE REPLACEMENT

K100389 is an FDA 510(k) clearance for HHC PUSH-BUTTON REPLACEMENT TURBINE FOR..., manufactured by Handpiece Headquarters. The device is a Class 1 Dental device with product code EFB cleared through the Traditional 510(k) pathway after a 177-day FDA review.

K100389 · Handpiece Headquarters · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2010
Decision
177d
Days
Class 1
Risk

K100389 is an FDA 510(k) clearance for the HHC PUSH-BUTTON REPLACEMENT TURBINE FOR MIDWEST TRADITION HANDPIECE MODEL MW .... Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by Handpiece Headquarters (Placentia, US). The FDA issued a Cleared decision on August 12, 2010 after a review of 177 days - an extended review 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: 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 Handpiece Headquarters devices

FDA 510(k) Submission Details - K100389

510(k) Number K100389 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 2010
Decision Date August 12, 2010
Days to Decision 177 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
49d slower than avg
Panel avg: 128d · This submission: 177d
Pathway characteristics
Predicate-based equivalence.

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 205
Devices cleared under the same product code (EFB) and FDA review panel - the closest regulatory comparables to K100389.
BOSWORTH AIR POLISHER
K100731 · Harry J. Bosworth Co. · Dec 2010
PACEMAKER HIGH-SPEED HANDPIECE MODEL PM-MQ, PM-M
K101551 · Delma Medical Instrument (Guangzhou) Co., Ltd. · Sep 2010
DENTAL HANDPIECES, MODELS: KARAM STD/MINI
K101717 · Aerobine, Inc. · Aug 2010
SYLE SMARTIP
K100833 · Osspray, Ltd. · Jun 2010
DENTAL HANDPIECE
K093971 · North West Medical Instrument (Group) Co., Ltd. · Apr 2010
CENTURY MODEL 105C
K093341 · Sybron Dental Specialties, Inc. · Apr 2010