Cleared Traditional

FLORIDA PROBE (K875076) - FDA 510(k) Clearance

Class I Dental device.

K875076 · Florida Probe Corp. · Dental device
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Mar 1988
Decision
92d
Days
Class 1
Risk

K875076 is an FDA 510(k) clearance for the FLORIDA PROBE. Classified as Probe, Periodontic (product code EIX), Class I - General Controls.

Submitted by Florida Probe Corp. (Gainesville, US). The FDA issued a Cleared decision on March 10, 1988 after a review of 92 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Florida Probe Corp. devices

Submission Details

510(k) Number K875076 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1987
Decision Date March 10, 1988
Days to Decision 92 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 127d · This submission: 92d
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.