Cleared Special

K032995 - SSS, MODEL 1072001 (STANDARD 4-HOLE MODEL) & 1072002 (STANDARD 2-HOLE MODEL)

K032995 is an FDA 510(k) clearance for SSS, manufactured by Micron Corp.. The device is a Class 2 Dental device with product code ELC cleared through the Special 510(k) pathway after a 56-day FDA review.

K032995 · Micron Corp. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2003
Decision
56d
Days
Class 2
Risk

K032995 is an FDA 510(k) clearance for the SSS, MODEL 1072001 (STANDARD 4-HOLE MODEL) & 1072002 (STANDARD 2-HOLE MODEL). Classified as Scaler, Ultrasonic (product code ELC), Class II - Special Controls.

Submitted by Micron Corp. (Ota-Ku, Tokyo, JP). The FDA issued a Cleared decision on November 20, 2003 after a review of 56 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.

FDA 510(k) Submission Details - K032995

510(k) Number K032995 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2003
Decision Date November 20, 2003
Days to Decision 56 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
72d faster than avg
Panel avg: 128d · This submission: 56d
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 164
Devices cleared under the same product code (ELC) and FDA review panel - the closest regulatory comparables to K032995.
SCALETRON PIEZO ULTRASOUND SCALER
K033120 · Pac-Dent International (Suzhou), Ltd. · Jan 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
DIAMONDCOAT ULTRASONIC INSERTS
K030111 · Dentsply International · Feb 2003
STERI-MATE STERILIZABLE HANDPIECE
K023697 · Dentsply International · Nov 2002
K032995 · SSS, MODEL 1072001 (STANDARD 4-HOLE MODEL) & 1072002 (STANDARD 2-HOLE MODEL)
Download PDF FDA Summary Micron Corp.