Cleared Traditional

DENTAL 911 (K941066) - FDA 510(k) Clearance

Class I Dental device.

K941066 · L.A.F. Industries, Inc. · Dental device
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May 1995
Decision
442d
Days
Class 1
Risk

K941066 is an FDA 510(k) clearance for the DENTAL 911. Classified as Zinc Oxide Eugenol (product code EMB), Class I - General Controls.

Submitted by L.A.F. Industries, Inc. (New York, US). The FDA issued a Cleared decision on May 24, 1995 after a review of 442 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3275 - 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: 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.

View all L.A.F. Industries, Inc. devices

Submission Details

510(k) Number K941066 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1994
Decision Date May 24, 1995
Days to Decision 442 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
315d slower than avg
Panel avg: 127d · This submission: 442d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EMB Zinc Oxide Eugenol
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.3275
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.