Cleared Traditional

K103019 - KJ MASK
(FDA 510(k) Clearance)

K103019 · Kj Meditech Co., Ltd. · Dental

Jun 2011

Decision

240d

Days

Class 2

Risk

K103019 is an FDA 510(k) clearance for the KJ MASK, a Headgear, Extraoral, Orthodontic (Class II — Special Controls, product code DZB), submitted by Kj Meditech Co., Ltd. (Fullerton, US). The FDA issued a Cleared decision on June 9, 2011, 240 days after receiving the submission on October 12, 2010. This device falls under the Dental review panel. Regulated under 21 CFR 872.5500.

Submission Details

510(k) Number	K103019 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 12, 2010
Decision Date	June 09, 2011
Days to Decision	240 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF