Cleared Traditional

K082294 - WESTAR SERIES DENTAL UNITS

K082294 is an FDA 510(k) clearance for WESTAR SERIES DENTAL UNITS, manufactured by Westar Medical Products, Inc.. The device is a Class 1 Dental device with product code EIA cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K082294 · Westar Medical Products, Inc. · Dental device
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Aug 2008
Decision
10d
Days
Class 1
Risk

K082294 is an FDA 510(k) clearance for the WESTAR SERIES DENTAL UNITS. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Westar Medical Products, Inc. (Mukilteo, US). The FDA issued a Cleared decision on August 22, 2008 after a review of 10 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 - K082294

510(k) Number K082294 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 2008
Decision Date August 22, 2008
Days to Decision 10 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
118d faster than avg
Panel avg: 128d · This submission: 10d
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

Intertek Testing Services
DANIEL W LEHTONEN

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 261
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K082294.
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COMFORTRONIC 4894 AND COMFORTDRIVE 200XDA HANDPIECE
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K080438 · North West Medical Instrument (Group) Co., Ltd. · Apr 2008
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K082294 · WESTAR SERIES DENTAL UNITS
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