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FDA 510(k)

PROTRACTION FACE MASK, REVERSE PULL FACE MASK MODEL KM-PVS, KM-PIS, KM-PVM, KM-PIM, MODEL KM-FMS, KM-FML, KM-FMF

K-Number: K111169 · 2011-10-03

ApplicantKwang Myung Daicom, Inc.
Decision Date2011-10-03
Product CodeDZB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PROTRACTION FACE MASK, REVERSE PULL FACE MASK MODEL KM-PVS, KM-PIS, KM-PVM, KM-PIM, MODEL KM-FMS, KM-FML, KM-FMF is the device name listed in this FDA 510(k) record. The listed applicant is Kwang Myung Daicom, Inc.. It received FDA 510(k) clearance on 2011-10-03 under 510(k) number K111169. The device is classified under product code DZB. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROTRACTION FACE MASK, REVERSE PULL FACE MASK MODEL KM-PVS, KM-PIS, KM-PVM, KM-PIM, MODEL KM-FMS, KM-FML, KM-FMF?

PROTRACTION FACE MASK, REVERSE PULL FACE MASK MODEL KM-PVS, KM-PIS, KM-PVM, KM-PIM, MODEL KM-FMS, KM-FML, KM-FMF is a medical device that received FDA 510(k) clearance on 2011-10-03. The listed applicant is Kwang Myung Daicom, Inc.. The 510(k) number is K111169.

When did PROTRACTION FACE MASK, REVERSE PULL FACE MASK MODEL KM-PVS, KM-PIS, KM-PVM, KM-PIM, MODEL KM-FMS, KM-FML, KM-FMF receive FDA 510(k) clearance?

PROTRACTION FACE MASK, REVERSE PULL FACE MASK MODEL KM-PVS, KM-PIS, KM-PVM, KM-PIM, MODEL KM-FMS, KM-FML, KM-FMF received FDA 510(k) clearance on 2011-10-03, under 510(k) number K111169.

Who is the listed applicant for PROTRACTION FACE MASK, REVERSE PULL FACE MASK MODEL KM-PVS, KM-PIS, KM-PVM, KM-PIM, MODEL KM-FMS, KM-FML, KM-FMF?

The FDA 510(k) record lists Kwang Myung Daicom, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PROTRACTION FACE MASK, REVERSE PULL FACE MASK MODEL KM-PVS, KM-PIS, KM-PVM, KM-PIM, MODEL KM-FMS, KM-FML, KM-FMF?

The FDA product code for PROTRACTION FACE MASK, REVERSE PULL FACE MASK MODEL KM-PVS, KM-PIS, KM-PVM, KM-PIM, MODEL KM-FMS, KM-FML, KM-FMF is DZB.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Related Devices (Code: DZB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K202855Orthodontic FacemaskIta.O Italian Orthodontic System S.R.L.K162543Reverse Pull Adjustable FacemaskSawbros Industries Pvt., Ltd.K103019KJ MASKKj Meditech Co., Ltd.K052553NITOM LOCKING FACEBOWRussell Samuels Orthodontic DesignK051751EQUA-PULL SAFETY RELEASE MODULEOrtho TechnologyK041718KELES FACEMASKGreat Lakes Orthodontics, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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