Cleared Traditional

PERIODONTAL PROBE - AUTOPROBE

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

About This 510(k) Submission

K880209 is an FDA 510(k) clearance for the PERIODONTAL PROBE - AUTOPROBE, a Gauge, Depth, Instrument, Dental (Class I — General Controls, product code EIL), submitted by Dentsply Intl. (York, US). The FDA issued a Cleared decision on April 27, 1988, 103 days after receiving the submission on January 15, 1988. This device falls under the Dental review panel. Regulated under 21 CFR 872.4565.

Submission Details

510(k) Number K880209 FDA.gov
FDA Decision Cleared SESE
Date Received January 15, 1988
Decision Date April 27, 1988
Days to Decision 103 days
Submission Type Traditional
Review Panel Dental (DE)
Summary —

Device Classification

Product Code EIL — Gauge, Depth, Instrument, Dental
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4565