Cleared Traditional

DENTIST IN A BOX DENTAL EMERGENCY KIT PLUS TOOTH TRAUMA CARE KIT

K120695 · Dentist IN A Box Pty., Ltd. · Dental
Jun 2012
Decision
97d
Days
Class 1
Risk

About This 510(k) Submission

K120695 is an FDA 510(k) clearance for the DENTIST IN A BOX DENTAL EMERGENCY KIT PLUS TOOTH TRAUMA CARE KIT, a Zinc Oxide Eugenol (Class I — General Controls, product code EMB), submitted by Dentist IN A Box Pty., Ltd. (Malvern, Victoria, AU). The FDA issued a Cleared decision on June 12, 2012, 97 days after receiving the submission on March 7, 2012. This device falls under the Dental review panel. Regulated under 21 CFR 872.3275.

Submission Details

510(k) Number K120695 FDA.gov
FDA Decision Cleared SESE
Date Received March 07, 2012
Decision Date June 12, 2012
Days to Decision 97 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

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