Cleared Traditional

K093971 - DENTAL HANDPIECE

K093971 is an FDA 510(k) clearance for DENTAL HANDPIECE, manufactured by North West Medical Instrument (Group) Co., Ltd.. The device is a Class 1 Dental device with product code EFB cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K093971 · 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 2010
Decision
119d
Days
Class 1
Risk

K093971 is an FDA 510(k) clearance for the DENTAL HANDPIECE. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by North West Medical Instrument (Group) Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on April 22, 2010 after a review of 119 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4200 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K093971

510(k) Number K093971 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 2009
Decision Date April 22, 2010
Days to Decision 119 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
9d faster than avg
Panel avg: 128d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

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 Consultant

Tuv Sud America, Inc.
DAWN TIBODEAU

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 - EFB Handpiece, Air-powered, Dental

All 237
Devices cleared under the same product code (EFB) and FDA review panel - the closest regulatory comparables to K093971.
DENTAL HANDPIECES, MODELS: KARAM STD/MINI
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K092933 · Redent-Nova , Ltd. · Jan 2010
STARCARE HANDPIECE MAINTENANCE UNIT
K093072 · Dentalez, Inc. · Dec 2009
K093971 · DENTAL HANDPIECE
Download PDF FDA Summary North West Medical In…