Cleared Traditional

K875076 - FLORIDA PROBE

K875076 is an FDA 510(k) clearance for FLORIDA PROBE, manufactured by Florida Probe Corp.. The device is a Class 1 Dental device with product code EIX cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K875076 · Florida Probe Corp. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K875076

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
36d faster than avg
Panel avg: 128d · This submission: 92d
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.