Cleared Traditional

K853841 - HARMO SONIC

K853841 is an FDA 510(k) clearance for HARMO SONIC, manufactured by U.S. Shizai Corp.. The device is a Class 2 Dental device with product code ELC cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K853841 · U.S. Shizai Corp. · Dental device
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Feb 1986
Decision
141d
Days
Class 2
Risk

K853841 is an FDA 510(k) clearance for the HARMO SONIC. Classified as Scaler, Ultrasonic (product code ELC), Class II - Special Controls.

Submitted by U.S. Shizai Corp. (Los Angeles, US). The FDA issued a Cleared decision on February 4, 1986 after a review of 141 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 U.S. Shizai Corp. devices

FDA 510(k) Submission Details - K853841

510(k) Number K853841 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 1985
Decision Date February 04, 1986
Days to Decision 141 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 128d · This submission: 141d
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 142
Devices cleared under the same product code (ELC) and FDA review panel - the closest regulatory comparables to K853841.
SONIC SCALER
K902413 · Dentsply Intl. · Aug 1990
PERIODONTAL IRRIGATING SOLUTION-D
K894247 · Dentsply Intl. · Oct 1989
ULTRASONIC SCALER 3000/ PROPHY-JET 30/ CAVI-JET 30
K864996 · Dentsply Intl. · Feb 1987
ULTRASONIC TOOTH SCALER MODEL DSCIOP
K852540 · Parkell, Inc. · Jul 1985
CAVI-MED
K842581 · Cooper Lasersonics, Inc. · Aug 1984
DENTAL ULTRASONIC SCALER/ENDOSONIC
K840141 · CooperVision, Inc. · Mar 1984