Cleared Traditional

K870280 - ACCUDENT ACCUPROBE

K870280 is an FDA 510(k) clearance for ACCUDENT ACCUPROBE, manufactured by Accudent, Inc.. The device is a Class 1 Dental device with product code EIX cleared through the Traditional 510(k) pathway after a 132-day FDA review.

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

K870280 is an FDA 510(k) clearance for the ACCUDENT ACCUPROBE. Classified as Probe, Periodontic (product code EIX), Class I - General Controls.

Submitted by Accudent, Inc. (Harrisonburg, US). The FDA issued a Cleared decision on June 8, 1987 after a review of 132 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 Accudent, Inc. devices

FDA 510(k) Submission Details - K870280

510(k) Number K870280 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 1987
Decision Date June 08, 1987
Days to Decision 132 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 128d · This submission: 132d
Pathway characteristics
Predicate-based equivalence.

EIX Device Classification - Class 1, General Controls

Product Code EIX Probe, Periodontic
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.