Cleared Traditional

K890493 - FLORIDA PROBE PERIODONTAL PROBE

K890493 is an FDA 510(k) clearance for FLORIDA PROBE PERIODONTAL PROBE, manufactured by Florida Probe Corp.. The device is a Class 1 Dental device with product code EIL cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K890493 · Florida Probe Corp. · Dental device
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Mar 1989
Decision
41d
Days
Class 1
Risk

K890493 is an FDA 510(k) clearance for the FLORIDA PROBE PERIODONTAL PROBE. Classified as Gauge, Depth, Instrument, Dental (product code EIL), Class I - General Controls.

Submitted by Florida Probe Corp. (Gainesville, US). The FDA issued a Cleared decision on March 13, 1989 after a review of 41 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 Florida Probe Corp. devices

FDA 510(k) Submission Details - K890493

510(k) Number K890493 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 1989
Decision Date March 13, 1989
Days to Decision 41 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 128d · This submission: 41d
Pathway characteristics
Predicate-based equivalence.

EIL Device Classification - Class 1, General Controls

Product Code EIL Gauge, Depth, Instrument, Dental
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.