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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 128d · 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 Consultant

Tuv Sud America, Inc.

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - EIA Unit, Operative Dental

All 257
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K080438.
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K071485 · Tpc Advanced Technology, Inc. · Aug 2007
OPTI
K063646 · Camsight Co., Inc. · Mar 2007
FLIGHT DENTAL SYSTEMS A-SERIES DENTAL OPERATIVE UNIT
K070196 · Hr Dental Products, Inc. · Jan 2007
K080438 · DENTAL UNIT WITH CHAIR
Download PDF FDA Summary North West Medical In…