Cleared Traditional

DENTIMEDIC DENTAL EMERGENCY KIT

K861681 · Dentimedic · Dental
Sep 1986
Decision
145d
Days
Class 1
Risk

About This 510(k) Submission

K861681 is an FDA 510(k) clearance for the DENTIMEDIC DENTAL EMERGENCY KIT, a Zinc Oxide Eugenol (Class I — General Controls, product code EMB), submitted by Dentimedic (Pocomoke City, US). The FDA issued a Cleared decision on September 23, 1986, 145 days after receiving the submission on May 1, 1986. This device falls under the Dental review panel. Regulated under 21 CFR 872.3275.

Submission Details

510(k) Number K861681 FDA.gov
FDA Decision Cleared SESE
Date Received May 01, 1986
Decision Date September 23, 1986
Days to Decision 145 days
Submission Type Traditional
Review Panel Dental (DE)
Summary —

Device Classification

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