Cleared Traditional

ARTICULATING PAPER (K832647) - FDA 510(k) Clearance

Class I Dental device.

K832647 · Ardent Intl., Inc. · Dental device
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Feb 1984
Decision
200d
Days
Class 1
Risk

K832647 is an FDA 510(k) clearance for the ARTICULATING PAPER. Classified as Paper, Articulation (product code EFH), Class I - General Controls.

Submitted by Ardent Intl., Inc. (Mchenry, US). The FDA issued a Cleared decision on February 21, 1984 after a review of 200 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6140 - 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 Ardent Intl., Inc. devices

Submission Details

510(k) Number K832647 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 1983
Decision Date February 21, 1984
Days to Decision 200 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d slower than avg
Panel avg: 127d · This submission: 200d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EFH Paper, Articulation
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6140
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.