Cleared Traditional

K100401 - SWERV MAGNETOSTRICTIVE ULTRASONIC SCALER SYSTEM

K100401 is an FDA 510(k) clearance for SWERV MAGNETOSTRICTIVE ULTRASONIC SCALE..., manufactured by Hu-Friedy Mfg. Co., Inc.. The device is a Class 2 Dental device with product code ELC cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K100401 · Hu-Friedy Mfg. Co., Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K100401

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
86d faster than avg
Panel avg: 128d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 164
Devices cleared under the same product code (ELC) and FDA review panel - the closest regulatory comparables to K100401.
EMS MINIMASTER LED
K093723 · E.M.S Electro Medical Systems S.A · Sep 2010
EMS PIEZON MASTER 700
K093000 · E.M.S Electro Medical Systems S.A · Jul 2010
A-DEC/W&H SYNEA SONIC SCALER HANDPIECE, MODELS ZA-55, ZA-55 L, ZA-55 LM, ZA-55M, SF1LM
K100647 · A-Dec, Inc. · Jul 2010
INSIGHT ULTRASONIC INSERTS
K092417 · Discus Dental, LLC · Dec 2009
SONIC AIR MM1500 + (MID), MODEL 50400014
K081268 · Micro-Mega Societe Anonyme · Aug 2009
AIR SONIC SCALER
K083059 · Dpm USA Corp. · Jan 2009
K100401 · SWERV MAGNETOSTRICTIVE ULTRASONIC SCALER SYSTEM
Download PDF FDA Summary Hu-Friedy Mfg. Co., I…