Cleared Traditional

K171150 - AW-100

K171150 is the FDA 510(k) clearance for AW-100 by Micron Corporation. It is a Class 2 Dental device (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

Submission Details

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.

Device Classification

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 38
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