Cleared Traditional

K042056 - AZ ULTRASONIC SYSTEM

K042056 is an FDA 510(k) clearance for AZ ULTRASONIC SYSTEM, manufactured by J. Morita USA, Inc.. The device is a Class 2 Dental device with product code ELC cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K042056 · J. Morita USA, Inc. · Dental device
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Sep 2004
Decision
62d
Days
Class 2
Risk

K042056 is an FDA 510(k) clearance for the AZ ULTRASONIC SYSTEM. Classified as Scaler, Ultrasonic (product code ELC), Class II - Special Controls.

Submitted by J. Morita USA, Inc. (Irvine, US). The FDA issued a Cleared decision on September 30, 2004 after a review of 62 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 - K042056

510(k) Number K042056 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 2004
Decision Date September 30, 2004
Days to Decision 62 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 128d · This submission: 62d
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 194
Devices cleared under the same product code (ELC) and FDA review panel - the closest regulatory comparables to K042056.
PERIOSCAN ULTRASONIC SCALER
K050354 · Sirona Dental Systems GmbH · Mar 2005
XP TECHNOLOGY ULTRASONIC SCALER
K042972 · American Eagle Instruments, Inc. · Mar 2005
DREAM CLEANSE S SCALER, DREAM COMPACT S SCALER
K033044 · American Green Dent. Mfg, Inc. · Dec 2004
APOZA ULTRASONIC SCALER AND EDODONTICS UNIT, SELECTOR U2
K033198 · Apoza Enterprise Co., Ltd. · Apr 2004
ULTRASONIC SCALER ELEGANCE MS-10 (25K)
K040396 · Rolence Enteprise, Inc. · Apr 2004
ULTRASONIC SCALER, MODELS VARIOS 350 LUX, VARIOS 350 (NO LIGHT), VARIOS 550, VARIOS 150 LUX, VARIOS 150 (NO LIGHT)
K031421 · Nakanishi, Inc. · Mar 2004
K042056 · AZ ULTRASONIC SYSTEM
Download PDF J. Morita USA, Inc.