Cleared Traditional

K133069 - CODENT LOW SPEED DENTAL HANDPIECES AND ...

K133069 is an FDA 510(k) clearance for CODENT LOW SPEED DENTAL HANDPIECES AND ..., manufactured by Codent Technical Industry Co., Ltd.. The device is a Class 1 Dental device with product code EFB cleared through the Traditional 510(k) pathway after a 389-day FDA review.

K133069 · Codent Technical Industry Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K133069

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.

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 92
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