Cleared Traditional

CAVITRON PROPHY-JET AIR POLISHING PROPHYLAXIS SYSTEM (K130862) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K130862 · Dentsply Intl., Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2013
Decision
117d
Days
Class 2
Risk

K130862 is an FDA 510(k) clearance for the CAVITRON PROPHY-JET AIR POLISHING PROPHYLAXIS SYSTEM. Classified as Scaler, Ultrasonic (product code ELC), Class II - Special Controls.

Submitted by Dentsply Intl., Inc. (York, US). The FDA issued a Cleared decision on July 23, 2013 after a review of 117 days - within the typical 510(k) review window.

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 Dentsply Intl., Inc. devices

Submission Details

510(k) Number K130862 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 2013
Decision Date July 23, 2013
Days to Decision 117 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
10d faster than avg
Panel avg: 127d · This submission: 117d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 36
Devices cleared under the same product code (ELC) and FDA review panel - the closest regulatory comparables to K130862.
tün® ultrasonic tips product family
K182145 · Engineered Endodontics · Jun 2019
Sonendo GentleWave System
K190359 · Sonendo, Inc. · Mar 2019
AW-100
K171150 · Micron Corporation · Mar 2018
CAVITRON RF ULTRASONIC SCALER SYSTEM WITH STERIMATE HANDPIECE, MODEL G-131
K052334 · Dentsply Intl. · Sep 2005
CARRIER TIPS
K031461 · Dentsply Intl. · Aug 2003
DENTSPLY CAVITRON SPS SCALER SYSTEM
K970123 · Dentsply Intl. · Apr 1997