Cleared Traditional

SWERV MAGNETOSTRICTIVE ULTRASONIC SCALER SYSTEM (K100401) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K100401 · Hu-Friedy Mfg. Co., Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2010
Decision
42d
Days
Class 2
Risk

K100401 is an FDA 510(k) clearance for the SWERV MAGNETOSTRICTIVE ULTRASONIC SCALER SYSTEM. Classified as Scaler, Ultrasonic (product code ELC), Class II - Special Controls.

Submitted by Hu-Friedy Mfg. Co., Inc. (Chicago, US). The FDA issued a Cleared decision on March 30, 2010 after a review of 42 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Hu-Friedy Mfg. Co., Inc. devices

Submission Details

510(k) Number K100401 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 2010
Decision Date March 30, 2010
Days to Decision 42 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 127d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 36
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