Cleared Traditional

K880209 - PERIODONTAL PROBE - AUTOPROBE (FDA 510(k) Clearance)

Class I Dental device.

K880209 · Dentsply Intl. · Dental device
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Apr 1988
Decision
103d
Days
Class 1
Risk

K880209 is an FDA 510(k) clearance for the PERIODONTAL PROBE - AUTOPROBE. Classified as Gauge, Depth, Instrument, Dental (product code EIL), Class I - General Controls.

Submitted by Dentsply Intl. (York, US). The FDA issued a Cleared decision on April 27, 1988 after a review of 103 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 Dentsply Intl. devices

Submission Details

510(k) Number K880209 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 15, 1988
Decision Date April 27, 1988
Days to Decision 103 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 127d · This submission: 103d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.