Cleared Traditional

DENTAL ROOT CANAL BACTERIALCIDAL LUBRICANT (K921713) - FDA 510(k) Clearance

K921713 · A and V Ent. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1993
Decision
576d
Days
-
Risk

K921713 is an FDA 510(k) clearance for the DENTAL ROOT CANAL BACTERIALCIDAL LUBRICANT. Classified as Cleanser, Root Canal (product code KJJ).

Submitted by A and V Ent. (Burlington, US). The FDA issued a Cleared decision on November 4, 1993 after a review of 576 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

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Submission Details

510(k) Number K921713 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 1992
Decision Date November 04, 1993
Days to Decision 576 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
449d slower than avg
Panel avg: 127d · This submission: 576d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KJJ Cleanser, Root Canal
Device Class -