Cleared Traditional

K100389 - HHC PUSH-BUTTON REPLACEMENT TURBINE FOR...

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)
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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
50d slower than avg
Panel avg: 127d · 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 91
Devices cleared under the same product code (EFB) and FDA review panel - the closest regulatory comparables to K100389.
PROPHY-MATE NEO
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K092289 · E.M.S Electro Medical Systems S.A · Oct 2009
AIR TORX, MODEL TRA-200, TRA-200-CP3, TRA-200-CP4
K091065 · J. Morita USA, Inc. · Oct 2009