Cleared Traditional

K080438 - DENTAL UNIT WITH CHAIR

K080438 is an FDA 510(k) clearance for DENTAL UNIT WITH CHAIR, manufactured by North West Medical Instrument (Group) Co., Ltd.. The device is a Class 1 Dental device with product code EIA cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K080438 · North West Medical Instrument (Group) Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2008
Decision
45d
Days
Class 1
Risk

K080438 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 North West Medical Instrument (Group) Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on April 4, 2008 after a review of 45 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6640 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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

FDA 510(k) Submission Details - K080438

510(k) Number K080438 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 2008
Decision Date April 04, 2008
Days to Decision 45 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 127d · This submission: 45d
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

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 122
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K080438.
STERN'S S250 NORDAM
K092917 · Cefla S.C. · Jun 2010
KODAK 1500 INTRAORAL CAMERA
K091186 · Carestream Health, Inc. · Aug 2009
A-DEC 334/335 DELIVERY SYSTEM
K082985 · A-Dec, Inc. · Dec 2008
A-DEC SELF-CONTAINED WATER SYSTEM
K051657 · A-Dec, Inc. · Aug 2005
AEU-14CF EXPENDITION
K050201 · Aseptico, Inc. · Mar 2005
SPACELINE EMCIA, MODEL CU580
K043496 · J. Morita USA, Inc. · Feb 2005