Cleared Traditional

CODENT LOW SPEED DENTAL HANDPIECES AND ACCESSORIES (K133069) - FDA 510(k) Clearance

Class I Dental device.

K133069 · Codent Technical Industry Co., Ltd. · Dental device
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Oct 2014
Decision
389d
Days
Class 1
Risk

K133069 is an FDA 510(k) clearance for the CODENT LOW SPEED DENTAL HANDPIECES AND ACCESSORIES. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by Codent Technical Industry Co., Ltd. (Kaohsiung City, TW). The FDA issued a Cleared decision on October 24, 2014 after a review of 389 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Codent Technical Industry Co., Ltd. devices

Submission Details

510(k) Number K133069 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2013
Decision Date October 24, 2014
Days to Decision 389 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
262d slower than avg
Panel avg: 127d · This submission: 389d
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 40
Devices cleared under the same product code (EFB) and FDA review panel - the closest regulatory comparables to K133069.
Dental High-speed Handpiece and Accessories
K173943 · Microp Technology (Taiwan), Inc. · Jul 2018
High-speed Turbine Handpieces for Single Use
K172543 · Beijing Dongbo Dental Handpiece Co., Ltd. · Jul 2018
Concentrix MX-AC High-Speed Handpiece
K173465 · Dentalez, Inc. · Mar 2018
CENTURY MODEL 105C
K093341 · Sybron Dental Specialties, Inc. · Apr 2010
SUPERTORQUE HIGH-SPEED HANDPIECES AND GENTLEPOWER HANDPIECES AND ATTACHEMENTS
K073478 · Sybron Dental Specialties, Inc. · Sep 2008
DENTSPLY CAVITRON JET WAVE AIR POLISHING PROPHYLAXIS SYSTEM, MODEL G125
K041141 · Dentsply Intl. · Jun 2004