Cleared Special

K130410 - DENTAL UNIT WITH CHAIR (FDA 510(k) Clearance)

Class I Dental device.

K130410 · Xianyang North West Medical Instrument (Group) Co. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2013
Decision
157d
Days
Class 1
Risk

K130410 is an FDA 510(k) clearance for the DENTAL UNIT WITH CHAIR. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Xianyang North West Medical Instrument (Group) Co. (Shanghai, CN). The FDA issued a Cleared decision on July 26, 2013 after a review of 157 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6640 - 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Xianyang North West Medical Instrument (Group) Co. devices

Submission Details

510(k) Number K130410 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 2013
Decision Date July 26, 2013
Days to Decision 157 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
30d slower than avg
Panel avg: 127d · This submission: 157d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code EIA Unit, Operative Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6640
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.

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