Cleared Traditional

ULTRAPROX, INTERPROXIMAL TOOTHBRUSH (K860779) - FDA 510(k) Clearance

Class I Dental device.

K860779 · William J. Forni, D.D.S. · Dental device
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Apr 1986
Decision
30d
Days
Class 1
Risk

K860779 is an FDA 510(k) clearance for the ULTRAPROX, INTERPROXIMAL TOOTHBRUSH. Classified as Pick, Massaging (product code JET), Class I - General Controls.

Submitted by William J. Forni, D.D.S. (Santa Rosa, US). The FDA issued a Cleared decision on April 2, 1986 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6650 - 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 William J. Forni, D.D.S. devices

Submission Details

510(k) Number K860779 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1986
Decision Date April 02, 1986
Days to Decision 30 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 127d · This submission: 30d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JET Pick, Massaging
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6650
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.