Cleared Special

K150798 - Codent Low Speed Dental Handpieces and ...

K150798 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 Special 510(k) pathway after a 29-day FDA review.

K150798 · Codent Technical Industry Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2015
Decision
29d
Days
Class 1
Risk

K150798 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 April 24, 2015 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4200 - the FDA dental device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Codent Technical Industry Co., Ltd. devices

FDA 510(k) Submission Details - K150798

510(k) Number K150798 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 2015
Decision Date April 24, 2015
Days to Decision 29 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 127d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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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