Cleared Traditional

K053368 - INTERPROXIMAL REDUCTION SYSTEM

K053368 is an FDA 510(k) clearance for INTERPROXIMAL REDUCTION SYSTEM, manufactured by Dentsply International. The device is a Class 1 Dental device with product code EFB cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K053368 · Dentsply International · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2006
Decision
114d
Days
Class 1
Risk

K053368 is an FDA 510(k) clearance for the INTERPROXIMAL REDUCTION SYSTEM. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by Dentsply International (York, US). The FDA issued a Cleared decision on March 29, 2006 after a review of 114 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 Dentsply International devices

FDA 510(k) Submission Details - K053368

510(k) Number K053368 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 2005
Decision Date March 29, 2006
Days to Decision 114 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 128d · This submission: 114d
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 204
Devices cleared under the same product code (EFB) and FDA review panel - the closest regulatory comparables to K053368.
CST61 HIGH SPEED TURBINE HANDPIECE
K063110 · Shanghai Dental Instrument Factory · Oct 2006
K-SPRAY, MODEL 085-2715
K062418 · Scican · Oct 2006
PRODRIVE SYSTEMS REPLACEMENT TURBINE
K062219 · Prodrive Systems, Inc. · Aug 2006
DENTAL AIR-POWERED HANDPIECE, MODELS TIGER 100, 101, 200, 201 AND 202
K052822 · Thunder Tiger Corp. · Jan 2006
PANA-SPRAY
K052700 · Nsk America Corp. · Dec 2005
MK-DENT LOW SPEED HANDPIECES AND ACCESSORIES INCLUDING SPARE PARTS, TUBINGS, AND LIGHT POWER SYSTEM, MODELS: LS2011
K051872 · Mk-Dent GmbH · Oct 2005