Cleared Traditional

K964596 - PROSELECT 3 PERIDONTAL THERAPY SYSTEM

K964596 is an FDA 510(k) clearance for PROSELECT 3 PERIDONTAL THERAPY SYSTEM, manufactured by Professional Dental Mfg., Inc.. The device is a Class 2 Dental device with product code ELC cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K964596 · Professional Dental Mfg., Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1997
Decision
155d
Days
Class 2
Risk

K964596 is an FDA 510(k) clearance for the PROSELECT 3 PERIDONTAL THERAPY SYSTEM. Classified as Scaler, Ultrasonic (product code ELC), Class II - Special Controls.

Submitted by Professional Dental Mfg., Inc. (Batesville, US). The FDA issued a Cleared decision on April 22, 1997 after a review of 155 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 Professional Dental Mfg., Inc. devices

FDA 510(k) Submission Details - K964596

510(k) Number K964596 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1996
Decision Date April 22, 1997
Days to Decision 155 days
Submission Type Traditional
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
28d slower than avg
Panel avg: 127d · This submission: 155d
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 85
Devices cleared under the same product code (ELC) and FDA review panel - the closest regulatory comparables to K964596.
BIOSONIC ULTRASONIC SCALER SYSTEM
K983727 · Coltene/Whaledent, Inc. · Jan 1999
PIEZO TRONIC
K982793 · Advanced Medical Devices, Inc. · Oct 1998
SP4044 & SP4055 LUX MODULES
K972026 · Satelec · Jul 1997
DENTSPLY CAVITRON SPS SCALER SYSTEM
K970123 · Dentsply Intl. · Apr 1997
CAVITRON JET WITH SPS SYSTEM
K970342 · Dentsply Intl. · Apr 1997
SUPRASSON P5 BOOSTER
K961158 · Satelec · May 1996