Cleared Traditional

K880209 - PERIODONTAL PROBE - AUTOPROBE

K880209 is an FDA 510(k) clearance for PERIODONTAL PROBE - AUTOPROBE, manufactured by Dentsply Intl.. The device is a Class 1 Dental device with product code EIL cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K880209 · Dentsply Intl. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K880209

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 127d · This submission: 103d
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.