Cleared Traditional

K843017 - ABSORBENT ENDODONTIC POINT

K843017 is an FDA 510(k) clearance for ABSORBENT ENDODONTIC POINT, manufactured by United Dental Mfg., Inc.. The device is a Class 1 Dental device with product code EKN cleared through the Traditional 510(k) pathway after a 162-day FDA review.

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

FDA 510(k) Submission Details - K843017

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
34d slower than avg
Panel avg: 128d · This submission: 162d
Pathway characteristics
Predicate-based equivalence.

EKN Device Classification - Class 1, General Controls

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.