Cleared Traditional

K171150 - AW-100

K171150 is an FDA 510(k) clearance for AW-100, manufactured by Micron Corporation. The device is a Class 2 Dental device with product code ELC cleared through the Traditional 510(k) pathway after a 323-day FDA review.

K171150 · Micron Corporation · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2018
Decision
323d
Days
Class 2
Risk

K171150 is an FDA 510(k) clearance for the AW-100. Classified as Scaler, Ultrasonic (product code ELC), Class II - Special Controls.

Submitted by Micron Corporation (Ota-Ku, Tokyo, JP). The FDA issued a Cleared decision on March 8, 2018 after a review of 323 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4850 - 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Micron Corporation devices

FDA 510(k) Submission Details - K171150

510(k) Number K171150 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 2017
Decision Date March 08, 2018
Days to Decision 323 days
Submission Type Traditional
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
196d slower than avg
Panel avg: 127d · This submission: 323d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ELC Device Classification - Class 2, Special Controls

Product Code ELC Scaler, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4850
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - ELC Scaler, Ultrasonic

All 120
Devices cleared under the same product code (ELC) and FDA review panel - the closest regulatory comparables to K171150.
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