Cleared Traditional

K990546 - DELSONIC 2000

K990546 is the FDA 510(k) clearance for DELSONIC 2000 by Sds Dental, Inc.. It is a Class 2 Dental device (product code ELC) cleared through the Traditional 510(k) pathway after a 256-day FDA review.

K990546 · Sds Dental, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1999
Decision
256d
Days
Class 2
Risk

K990546 is an FDA 510(k) clearance for the DELSONIC 2000. Classified as Scaler, Ultrasonic (product code ELC), Class II - Special Controls.

Submitted by Sds Dental, Inc. (Fort Lauderdale, US). The FDA issued a Cleared decision on November 5, 1999 after a review of 256 days - an extended review 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: 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 Sds Dental, Inc. devices

Submission Details

510(k) Number K990546 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 1999
Decision Date November 05, 1999
Days to Decision 256 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
129d slower than avg
Panel avg: 127d · This submission: 256d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 59
Devices cleared under the same product code (ELC) and FDA review panel - the closest regulatory comparables to K990546.
SIROSON L AND SIROSONIC L ULTRASONIC SCALERS
K033640 · Sirona Dental Systems GmbH · Dec 2003
CARRIER TIPS
K031461 · Dentsply Intl. · Aug 2003
PREMIER ULTRASONIC SCALER AND INSERTS
K010195 · Premier Dental Products Co. · Apr 2001
DENTSPLY CAVITRON SPS SCALER SYSTEM
K970123 · Dentsply Intl. · Apr 1997
CAVITRON JET WITH SPS SYSTEM
K970342 · Dentsply Intl. · Apr 1997
LE CLEAN MACHINE
K950240 · Parkell, Inc. · Apr 1995