Cleared Traditional

K990546 - DELSONIC 2000

K990546 is an FDA 510(k) clearance for DELSONIC 2000, manufactured by Sds Dental, Inc.. The device is a Class 2 Dental device with 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

FDA 510(k) Submission Details - K990546

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
Combination Product No
PCCP Authorized No
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.

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 130
Devices cleared under the same product code (ELC) and FDA review panel - the closest regulatory comparables to K990546.
ART-M3 25K, MODEL M3-1-ART2-A1
K994203 · Bonart Co., Ltd. · Mar 2000
ART-P3, MODEL P3-1-ART-A1
K994299 · Bonart Co., Ltd. · Mar 2000
EMS KERMIT
K992504 · (Ems Sa) Electro Medical Systems · Jan 2000
VIP 60 (2H), MODEL 115-000-1, VIP 60 (4H), MODEL 115-000-2
K991239 · Micron Corp. · Oct 1999
EMS SURFACE MOUNT SCALER
K991874 · (Ems Sa) Electro Medical Systems · Jul 1999
SONIC SCALER WITH FIBER OPTIC, MODEL NAS-L, SONIC SCALER WITHOUT FIBER OPTIC, MODEL NAS-NL
K991021 · Nsk Nakanishi, Inc. · Jun 1999