Cleared Special

K023697 - STERI-MATE STERILIZABLE HANDPIECE

K023697 is an FDA 510(k) clearance for STERI-MATE STERILIZABLE HANDPIECE, manufactured by Dentsply International. The device is a Class 2 Dental device with product code ELC cleared through the Special 510(k) pathway after a 2-day FDA review.

K023697 · Dentsply International · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2002
Decision
2d
Days
Class 2
Risk

K023697 is an FDA 510(k) clearance for the STERI-MATE STERILIZABLE HANDPIECE. Classified as Scaler, Ultrasonic (product code ELC), Class II - Special Controls.

Submitted by Dentsply International (York, US). The FDA issued a Cleared decision on November 6, 2002 after a review of 2 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4850 - the FDA dental device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Dentsply International devices

FDA 510(k) Submission Details - K023697

510(k) Number K023697 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 2002
Decision Date November 06, 2002
Days to Decision 2 days
Submission Type Special
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
125d faster than avg
Panel avg: 127d · This submission: 2d
Pathway characteristics
Modification to existing cleared device.

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 K023697.
BOBCAT PRO SCALER SYSTEM, MODEL G-130
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K010195 · Premier Dental Products Co. · Apr 2001
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K970123 · Dentsply Intl. · Apr 1997