Cleared Traditional

K960245 - VIP VICTOR INTERACTIVE PROBE

K960245 is an FDA 510(k) clearance for VIP VICTOR INTERACTIVE PROBE, manufactured by Pro-Dentec. The device is a Class 1 Dental device with product code EIX cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K960245 · Pro-Dentec · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 1996
Decision
79d
Days
Class 1
Risk

K960245 is an FDA 510(k) clearance for the VIP VICTOR INTERACTIVE PROBE. Classified as Probe, Periodontic (product code EIX), Class I - General Controls.

Submitted by Pro-Dentec (Chicago, US). The FDA issued a Cleared decision on April 4, 1996 after a review of 79 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4565 - 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.

FDA 510(k) Submission Details - K960245

510(k) Number K960245 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 1996
Decision Date April 04, 1996
Days to Decision 79 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
49d faster than avg
Panel avg: 128d · This submission: 79d
Pathway characteristics
Predicate-based equivalence.

EIX Device Classification - Class 1, General Controls

Product Code EIX Probe, Periodontic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4565
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.

Regulatory Peers - EIX Probe, Periodontic

All 8
Devices cleared under the same product code (EIX) and FDA review panel - the closest regulatory comparables to K960245.
THE VIVACARE T.P.S. PROBE
K944848 · Rms Div. · Dec 1994
PROBE TIP/PERI PROBE/PERI PROBE COMP.
K936221 · Pd International AB · Aug 1994
ALBUMIN REAGENT
K890333 · Alpkem Corp. · Feb 1989
ACCUTEK PERIODONTAL PROBE
K880827 · Sweet Micro Systems, Inc. · Apr 1988
FLORIDA PROBE
K875076 · Florida Probe Corp. · Mar 1988
ACCUDENT ACCUPROBE
K870280 · Accudent, Inc. · Jun 1987
K960245 · VIP VICTOR INTERACTIVE PROBE
Download PDF FDA Summary Pro-Dentec