Cleared Traditional

K944848 - THE VIVACARE T.P.S. PROBE (FDA 510(k) Clearance)

Class I Dental device.

K944848 · Rms Div. · Dental device
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Dec 1994
Decision
75d
Days
Class 1
Risk

K944848 is an FDA 510(k) clearance for the THE VIVACARE T.P.S. PROBE. Classified as Probe, Periodontic (product code EIX), Class I - General Controls.

Submitted by Rms Div. (Amherst, US). The FDA issued a Cleared decision on December 14, 1994 after a review of 75 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.

View all Rms Div. devices

Submission Details

510(k) Number K944848 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 1994
Decision Date December 14, 1994
Days to Decision 75 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
52d faster than avg
Panel avg: 127d · This submission: 75d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.