Cleared Traditional

VUTLER G.U.M. WITH FLUORIDE (K952091) - FDA 510(k) Clearance

Class I Dental device.

K952091 · John O. Butler Co. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1995
Decision
56d
Days
Class 1
Risk

K952091 is an FDA 510(k) clearance for the VUTLER G.U.M. WITH FLUORIDE. Classified as Floss, Dental (product code JES), Class I - General Controls.

Submitted by John O. Butler Co. (Chicago, US). The FDA issued a Cleared decision on June 28, 1995 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6390 - 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 John O. Butler Co. devices

Submission Details

510(k) Number K952091 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 1995
Decision Date June 28, 1995
Days to Decision 56 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
71d faster than avg
Panel avg: 127d · This submission: 56d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JES Floss, Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6390
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.