Cleared Traditional

TONY RISO 25/30 MULTIFUNCTION SCALER (K964320) - FDA 510(k) Clearance

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

K964320 · Tony Riso Co., Inc. · Dental device
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Jan 1997
Decision
86d
Days
Class 2
Risk

K964320 is an FDA 510(k) clearance for the TONY RISO 25/30 MULTIFUNCTION SCALER. Classified as Scaler, Ultrasonic (product code ELC), Class II - Special Controls.

Submitted by Tony Riso Co., Inc. (Miami Beach, US). The FDA issued a Cleared decision on January 23, 1997 after a review of 86 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Tony Riso Co., Inc. devices

Submission Details

510(k) Number K964320 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 1996
Decision Date January 23, 1997
Days to Decision 86 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 127d · This submission: 86d
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 K964320.
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