Cleared Traditional

ACCUDENT ACCUPROBE

K870280 · Accudent, Inc. · Dental
Jun 1987
Decision
132d
Days
Class 1
Risk

About This 510(k) Submission

K870280 is an FDA 510(k) clearance for the ACCUDENT ACCUPROBE, a Probe, Periodontic (Class I — General Controls, product code EIX), submitted by Accudent, Inc. (Harrisonburg, US). The FDA issued a Cleared decision on June 8, 1987, 132 days after receiving the submission on January 27, 1987. This device falls under the Dental review panel. Regulated under 21 CFR 872.4565.

Submission Details

510(k) Number K870280 FDA.gov
FDA Decision Cleared SESE
Date Received January 27, 1987
Decision Date June 08, 1987
Days to Decision 132 days
Submission Type Traditional
Review Panel Dental (DE)
Summary —

Device Classification

Product Code EIX — Probe, Periodontic
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4565