Cleared Special

K130410 - DENTAL UNIT WITH CHAIR

K130410 is an FDA 510(k) clearance for DENTAL UNIT WITH CHAIR, manufactured by Xianyang North West Medical Instrument (Group) Co.. The device is a Class 1 Dental device with product code EIA cleared through the Special 510(k) pathway after a 157-day FDA review.

K130410 · Xianyang North West Medical Instrument (Group) Co. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K130410

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 128d · This submission: 157d
Pathway characteristics
Modification to existing cleared device.

EIA Device Classification - Class 1, General Controls

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.

Regulatory Peers - EIA Unit, Operative Dental

All 246
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K130410.
AJAX DENTAL UNIT
K132245 · Pro Dental Services, LLC · Sep 2014
ERGONOMIC PRODUCTS WORKSTATION
K132315 · Ergonomic Products, Inc. · Apr 2014
DIPLOMAT
K130534 · Diplomat Dental S.R.O. · Oct 2013
ELEVANCE
K120239 · Midmark · Aug 2012
TRITON SELF CONTAINED DENTAL SYSTEM, TRITON SELF CONTAINED DENTAL SYSTEM, WITH CASE
K110481 · Asi Medical, Inc. · Apr 2012
DYNAMIC DU SERIES PORTABLE DENTAL UNIT
K111907 · Shanghai Dynamic Industry Co., Ltd. · Dec 2011