Cleared Traditional

K033764 - SP NEWTRON MODULE

K033764 is an FDA 510(k) clearance for SP NEWTRON MODULE, manufactured by Satelec. The device is a Class 2 Dental device with product code ELC cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K033764 · Satelec · Dental device
Download Printable Device Report (PDF)
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Mar 2004
Decision
90d
Days
Class 2
Risk

K033764 is an FDA 510(k) clearance for the SP NEWTRON MODULE. Classified as Scaler, Ultrasonic (product code ELC), Class II - Special Controls.

Submitted by Satelec (Merignac, FR). The FDA issued a Cleared decision on March 1, 2004 after a review of 90 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 Satelec devices

FDA 510(k) Submission Details - K033764

510(k) Number K033764 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 2003
Decision Date March 01, 2004
Days to Decision 90 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
37d faster than avg
Panel avg: 127d · This submission: 90d
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 74
Devices cleared under the same product code (ELC) and FDA review panel - the closest regulatory comparables to K033764.
PERIOSCAN ULTRASONIC SCALER
K050354 · Sirona Dental Systems GmbH · Mar 2005
AZ ULTRASONIC SYSTEM
K042056 · J. Morita USA, Inc. · Sep 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
SIROSON L AND SIROSONIC L ULTRASONIC SCALERS
K033640 · Sirona Dental Systems GmbH · Dec 2003
BOBCAT PRO SCALER SYSTEM, MODEL G-130
K033705 · Dentsply International · Dec 2003
CARRIER TIPS
K031461 · Dentsply Intl. · Aug 2003