Cleared Traditional

K033213 - CODENT DENTAL AIR-POWERED HANDPIECE

K033213 is an FDA 510(k) clearance for CODENT DENTAL AIR-POWERED HANDPIECE, 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 126-day FDA review.

K033213 · Codent Technical Industry Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2004
Decision
126d
Days
Class 1
Risk

K033213 is an FDA 510(k) clearance for the CODENT DENTAL AIR-POWERED HANDPIECE, MODEL HPS. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by Codent Technical Industry Co., Ltd. (Hsin-Chu City, TW). The FDA issued a Cleared decision on February 6, 2004 after a review of 126 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 Codent Technical Industry Co., Ltd. devices

FDA 510(k) Submission Details - K033213

510(k) Number K033213 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 2003
Decision Date February 06, 2004
Days to Decision 126 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
1d faster than avg
Panel avg: 127d · This submission: 126d
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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