Cleared Traditional

ABSORBENT ENDODONTIC POINT (K843017) - FDA 510(k) Clearance

Class I Dental device.

K843017 · United Dental Mfg., Inc. · Dental device
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Jan 1985
Decision
162d
Days
Class 1
Risk

K843017 is an FDA 510(k) clearance for the ABSORBENT ENDODONTIC POINT. Classified as Point, Paper, Endodontic (product code EKN), Class I - General Controls.

Submitted by United Dental Mfg., Inc. (West Palm Beach, US). The FDA issued a Cleared decision on January 9, 1985 after a review of 162 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3830 - 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 United Dental Mfg., Inc. devices

Submission Details

510(k) Number K843017 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 1984
Decision Date January 09, 1985
Days to Decision 162 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d slower than avg
Panel avg: 127d · This submission: 162d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EKN Point, Paper, Endodontic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.3830
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.