Cleared Traditional

K000846 - TKD SCALERS

K000846 is an FDA 510(k) clearance for TKD SCALERS, manufactured by Orasystems. The device is a Class 2 Dental device with product code ELC cleared through the Traditional 510(k) pathway after a 264-day FDA review.

K000846 · Orasystems · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2000
Decision
264d
Days
Class 2
Risk

K000846 is an FDA 510(k) clearance for the TKD SCALERS. Classified as Scaler, Ultrasonic (product code ELC), Class II - Special Controls.

Submitted by Orasystems (Morris Plains, US). The FDA issued a Cleared decision on December 4, 2000 after a review of 264 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 Orasystems devices

FDA 510(k) Submission Details - K000846

510(k) Number K000846 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 2000
Decision Date December 04, 2000
Days to Decision 264 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
137d slower than avg
Panel avg: 127d · This submission: 264d
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 119
Devices cleared under the same product code (ELC) and FDA review panel - the closest regulatory comparables to K000846.
STERI-MATE STERILIZABLE HANDPIECE
K023697 · Dentsply International · Nov 2002
PREMIER ULTRASONIC SCALER AND INSERTS
K010195 · Premier Dental Products Co. · Apr 2001
VECTOR
K002122 · Air Techniques, Inc. · Dec 2000
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