Cleared Traditional

SPRAY & CLEAN HANDPIECE CLEANER& LUBRICANT MAXIMA HANDPIECE CLEANER & LUBRICANT EZCARE HANDPIECE CLEANER & LUBRICANT (K113674) - FDA 510(k) Clearance

Class I Dental device.

K113674 · Handpiece Headquarters, Inc. - Hpr, Inc. · Dental device
Download Printable Device Report (PDF)
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Apr 2012
Decision
113d
Days
Class 1
Risk

K113674 is an FDA 510(k) clearance for the SPRAY & CLEAN HANDPIECE CLEANER& LUBRICANT MAXIMA HANDPIECE CLEANER & LUBRICA.... Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by Handpiece Headquarters, Inc. - Hpr, Inc. (Placentia, US). The FDA issued a Cleared decision on April 5, 2012 after a review of 113 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 Handpiece Headquarters, Inc. - Hpr, Inc. devices

Submission Details

510(k) Number K113674 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 2011
Decision Date April 05, 2012
Days to Decision 113 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
14d faster than avg
Panel avg: 127d · This submission: 113d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 260
Devices cleared under the same product code (EFB) and FDA review panel - the closest regulatory comparables to K113674.
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High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22), Dental Low Speed Handpieces including Straight and Geared Angle Handpieces and Air Motors (Straight Handpieces: SCHD05-S, SCHD16-S, SCHD17-S, SCHD24-S, SCHD27-S Geared Angle Handpieces: SCHD05-C, SCHD06-C, SCHD16-C, SCHD17-C, SCHD24-C, SCHD27-C, SCHD29-S, SCHB4, SCHB5, SCHB20, SCHB64 Air Motors: SCHD16-M, SCHD17-M, SCHD24-M, SCHD27-M)
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