Cleared Traditional

ENDODONTIC POST W/ ACCESSORIES (K923232) - FDA 510(k) Clearance

Class I Dental device.

K923232 · Veillette Ent. · Dental device
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Mar 1993
Decision
247d
Days
Class 1
Risk

K923232 is an FDA 510(k) clearance for the ENDODONTIC POST W/ ACCESSORIES. Classified as Post, Root Canal (product code ELR), Class I - General Controls.

Submitted by Veillette Ent. (Mission Veijo, US). The FDA issued a Cleared decision on March 5, 1993 after a review of 247 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3810 - 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 Veillette Ent. devices

Submission Details

510(k) Number K923232 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1992
Decision Date March 05, 1993
Days to Decision 247 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
120d slower than avg
Panel avg: 127d · This submission: 247d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code ELR Post, Root Canal
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.3810
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.