Cleared Special

K033705 - BOBCAT PRO SCALER SYSTEM

K033705 is an FDA 510(k) clearance for BOBCAT PRO SCALER SYSTEM, 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 9-day FDA review.

K033705 · Dentsply International · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2003
Decision
9d
Days
Class 2
Risk

K033705 is an FDA 510(k) clearance for the BOBCAT PRO SCALER SYSTEM, MODEL G-130. Classified as Scaler, Ultrasonic (product code ELC), Class II - Special Controls.

Submitted by Dentsply International (York, US). The FDA issued a Cleared decision on December 4, 2003 after a review of 9 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 - K033705

510(k) Number K033705 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 2003
Decision Date December 04, 2003
Days to Decision 9 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
118d faster than avg
Panel avg: 127d · This submission: 9d
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 K033705.
ULTRASONIC SCALER, MODELS VARIOS 350 LUX, VARIOS 350 (NO LIGHT), VARIOS 550, VARIOS 150 LUX, VARIOS 150 (NO LIGHT)
K031421 · Nakanishi, Inc. · Mar 2004
SP NEWTRON MODULE
K033764 · Satelec · Mar 2004
SIROSON L AND SIROSONIC L ULTRASONIC SCALERS
K033640 · Sirona Dental Systems GmbH · 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