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

Name: FDA 510(k) clearance K111169
Creator: U.S. Food and Drug Administration
Published: 2011-10-03

Substantially Equivalent

Kwang Myung Daicom, Inc.

FDA 510(k) clearance K111169 for PROTRACTION FACE MASK, REVERSE PULL FACE MASK MODEL KM-PVS, KM-PIS, KM-PVM, KM-PIM, MODEL KM-FMS, KM-FML, KM-FMF, Substantially Equivalent on 2011-10-03. Applicant: Kwang Myung Daicom, Inc.. Device class: 2.

Clearance details

Applicant: Kwang Myung Daicom, Inc.
Product code: Code DZB
Device class: Class 2
Regulation: 21 CFR 872.5500
Advisory panel: Dental
Date received: 2011-04-26
Decision date: 2011-10-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fullerton, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DZB

view all

K202855 — Orthodontic Facemask2021-06-21
K162543 — Reverse Pull Adjustable Facemask2017-08-28
K103019 — KJ MASK2011-06-09
K052553 — NITOM LOCKING FACEBOW2005-12-22
K051751 — EQUA-PULL SAFETY RELEASE MODULE2005-07-22

Data sourced from openFDA. This site is unofficial and independent of the FDA.