Cleared Traditional

DENTAL 911

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

About This 510(k) Submission

K941066 is an FDA 510(k) clearance for the DENTAL 911, a Zinc Oxide Eugenol (Class I — General Controls, product code EMB), submitted by L.A.F. Industries, Inc. (New York, US). The FDA issued a Cleared decision on May 24, 1995, 442 days after receiving the submission on March 8, 1994. This device falls under the Dental review panel. Regulated under 21 CFR 872.3275.

Submission Details

510(k) Number K941066 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code EMB — Zinc Oxide Eugenol
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.3275