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

K111169 · Kwang Myung Daicom, Inc. · DZB · Oct 3, 2011 · Dental

Device Facts

• Record ID: K111169
• Device Name: PROTRACTION FACE MASK, REVERSE PULL FACE MASK MODEL KM-PVS, KM-PIS, KM-PVM, KM-PIM, MODEL KM-FMS, KM-FML, KM-FMF
• Applicant: Kwang Myung Daicom, Inc.
• Product Code: DZB · Dental
• Decision Date: Oct 3, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Protraction Face Mask and Reverse Pull Face Mask are used as a treatment option for Class III malocclusions.

Device Story

Protraction Face Mask / Reverse Pull Face Mask is an extraoral orthodontic headgear device. It is used by orthodontists to treat Class III malocclusions by applying force to the maxilla. The device consists of a frame worn externally on the face, which provides a framework for applying orthopedic traction to the maxillary complex. It is a mechanical device used in a clinical setting under the supervision of a dental professional to correct skeletal or dental discrepancies.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Extraoral orthodontic headgear; mechanical frame design; non-powered; intended for external facial application to provide orthopedic traction.

Indications for Use

Indicated for patients requiring treatment for Class III malocclusions.

Regulatory Classification

Identification

An extraoral orthodontic headgear is a device intended for use with an orthodontic appliance to exert pressure on the teeth from outside the mouth. The headgear has a strap intended to wrap around the patient's neck or head and an inner bow portion intended to be fastened to the orthodontic appliance in the patient's mouth.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows a logo with a stylized bird-like figure composed of three curved lines, resembling feathers or wings. The logo is encircled by text that reads 'U.S. DEPARTMENT OF HEALTH & HUMAN SERVICES' in a circular arrangement. The text is in all capital letters and is oriented to follow the curve of the circle.

Food and Drug Administration 1 0903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Kwang Myung Daicom, Incorporated C/O Ms. Priscilla Chung Regulatory Affairs Consultant LK Consulting Group 951 Starbuck Street, Unit J Fullerton, California 92833

OCT - 3 201

Re: K111169

Trade/Device Name: Protraction Face Mask / Reverse Pull Face Mask Regulation Number: 21 CFR 872.5500 Regulation Name: Extraoral Orthodontic Headgear Regulatory Class: II Product Code: DZB Dated: September 12, 2011 Received: September 20, 2011

Dear Ms. Chung:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approvate of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufactring practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRF, not evaluate information related to contract liability warranties. We remind you, fowever, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements, This 21, and 800 to 670. In
Position Register.

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Page 2- Ms. Chung

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820): and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ uem115809.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.hun.

Sincerely yours.

Nh for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K111169

Device Name: Protraction Face Mask / Reverse Pull Face Mask

Indications For Use:

Protraction Face Mask and Reverse Pull Face Mask are used as a treatment option for Class III malocclusions.

- النتشارين - - -

Prescription Use (Per 21 CFR 801 Subpart D)

ﻨﺎ ﻣﻦ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ

AND/OR

Over-The Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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| Division of Anesthesiology, General Hospital Infection Control, Dental Devices | |
| 510(k) Number: | K111169 |