Cleared Traditional

K083059 - AIR SONIC SCALER

K083059 is an FDA 510(k) clearance for AIR SONIC SCALER, manufactured by Dpm USA Corp.. The device is a Class 2 Dental device with product code ELC cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K083059 · Dpm USA Corp. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2009
Decision
108d
Days
Class 2
Risk

K083059 is an FDA 510(k) clearance for the AIR SONIC SCALER. Classified as Scaler, Ultrasonic (product code ELC), Class II - Special Controls.

Submitted by Dpm USA Corp. (Miami, US). The FDA issued a Cleared decision on January 30, 2009 after a review of 108 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.

FDA 510(k) Submission Details - K083059

510(k) Number K083059 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 2008
Decision Date January 30, 2009
Days to Decision 108 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
20d faster than avg
Panel avg: 128d · This submission: 108d
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 164
Devices cleared under the same product code (ELC) and FDA review panel - the closest regulatory comparables to K083059.
SWERV MAGNETOSTRICTIVE ULTRASONIC SCALER SYSTEM
K100401 · Hu-Friedy Mfg. Co., Inc. · Mar 2010
INSIGHT ULTRASONIC INSERTS
K092417 · Discus Dental, LLC · Dec 2009
SONIC AIR MM1500 + (MID), MODEL 50400014
K081268 · Micro-Mega Societe Anonyme · Aug 2009
STER-MATE STERILE LAVAGE KIT
K082973 · Dentsply Interntional · Jan 2009
SONICFLEX 2003 AND SONICFLEX LUX 2003 L WITH INSTRUMENT TIPS
K080089 · Sybron Dental Specialties, Inc. · Sep 2008
BONART ULTRASONIC SCALER, MOEDLS ART-P3II PRO AND ART-MII PRO
K081550 · Bonart Co., Ltd. · Aug 2008
K083059 · AIR SONIC SCALER
Download PDF FDA Summary Dpm USA Corp.