Cleared Traditional

K111169 - PROTRACTION FACE MASK, REVERSE PULL FACE MASK MODEL KM-PVS, KM-PIS, KM-PVM, KM-PIM, MODEL KM-FMS, KM-FML, KM-FMF
(FDA 510(k) Clearance)

K111169 · Kwang Myung Daicom, Inc. · Dental

Oct 2011

Decision

160d

Days

Class 2

Risk

K111169 is an FDA 510(k) clearance for the PROTRACTION FACE MASK, REVERSE PULL FACE MASK MODEL KM-PVS, KM-PIS, KM-PVM, KM-PIM, MODEL KM-FMS, KM-FML, KM-FMF, a Headgear, Extraoral, Orthodontic (Class II — Special Controls, product code DZB), submitted by Kwang Myung Daicom, Inc. (Fullerton, US). The FDA issued a Cleared decision on October 3, 2011, 160 days after receiving the submission on April 26, 2011. This device falls under the Dental review panel. Regulated under 21 CFR 872.5500.

Submission Details

510(k) Number	K111169 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 26, 2011
Decision Date	October 03, 2011
Days to Decision	160 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement