(240 days)
Not Found
No
The device description and other sections do not mention any AI or ML components or functionalities. It describes a mechanical orthodontic device.
Yes
The device is used as a treatment option for Class III malocclusions and applies orthopedic or orthodontic forces to achieve a change in the position of the maxilla.
No
The device description states its purpose is to "exert orthopedic or orthodontic forces ... to effect a change in the position," indicating it is a treatment device, not a diagnostic one.
No
The device description explicitly states it is made of materials such as aluminum alloy, stainless steel, and plastic, and is intended to be placed on the face. This indicates it is a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- KJ Mask's Intended Use: The intended use of the KJ Mask is described as a "treatment option for Class III malocclusions" and to "exert orthopedic or orthodontic forces of the maxillary arch in order to effect a change in the position of the maxilla in relation to the mandible and other facial structures."
- KJ Mask's Mechanism: The device is a physical appliance placed on the face to apply force for orthodontic purposes. It does not involve testing biological samples.
Therefore, the KJ Mask falls under the category of a therapeutic or orthopedic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
KJ Mask is used as a treatment option for Class III malocclusions.
Product codes (comma separated list FDA assigned to the subject device)
DZB
Device Description
KJ Mask (KM 102-S, KM 201-L) is a device made of materials such as aluminum alloy, stainless steel and plastic intended to be placed on face for the purpose of orthodontics.
The device is constructed of four parts, a chip cup, forehead rest, cross bar and main frame. It is intended to exert orthopedic or orthodontic forces of the maxillary arch in order to effect a change in the position of the maxilla in relation to the mandible and other facial structures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Face, maxillary arch
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.5500 Extraoral orthodontic headgear.
(a)
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.(b)
Classification. Class II.
0
K/03019
JUN - 9 2011
ﻟﻠﻘﻀﺎﺀ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪ
510(k) Summary
This summary of 510(K) - safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: __ 09/29/2010 ___________________________________________________________________________________________________________________________________________________________________
-
- Company making the submission
| Submitter | |
|---|---|
| Name | KJ Meditech Co., Ltd. |
| Address | 959-21 Daechon-dong, Buk-gu,Gwang-ju, 500-470, |
| South Korea | |
| Phone | +82-62-972-5476 |
| Fax | +82-62-973-2809 |
| Contact | Nam-goong San, Assistant Manager |
-
- U.S Agent/Contact Person
LK Consulting Group 2341 W. Crescent Ave. # 3, Anaheim, CA 92801 Priscilla Juhee Chung Phone: 714-844-2612 Fax: 714-409-3357 Email: juhee.c@lkconsultinggroup.com
- U.S Agent/Contact Person
:
3. Device
Trade Name: KJ Mask Common Name: Orthodontic Face Mask Classification Name: Extraoral Orthodontic Headgear Classification regulation: 21CFR872.5500 Product Code: DZB
-
- Predicate Device:
ADP Face Mask by Ormco Corp. (K923556)
- Predicate Device:
-
- Description:
KJ Mask (KM 102-S, KM 201-L) is a device made of materials such as aluminum alloy, stainless steel and plastic intended to be placed on face for the purpose of
- Description:
1
orthodontics.
The device is constructed of four parts, a chip cup, forehead rest, cross bar and main frame. It is intended to exert orthopedic or orthodontic forces of the maxillary arch in order to effect a change in the position of the maxilla in relation to the mandible and other facial structures.
- Indication for use:
KJ Mask is used as a treatment option for Class III malocclusions.
- Basis for Substantial Equivalence
KJ Mask and the predicate device consist of almost the same components. The similarity in design between KJ Mask and the predicate device supports the safety and effectiveness of KJ mask for the indicated use.
KJ Mask is substantially equivalent to the predicate device in terms of indications, compositions, material, design, safety and effectiveness.
- Conclusion
Based on the information provided in this premarket notification, KJ Meditech Co., Ltd. concludes that KJ Mask is safe, effective and substantially equivalent to the predicate devices as described herein.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". Inside the circle is a stylized symbol that resembles a bird or a human figure with outstretched arms. The symbol is composed of three curved lines that create a sense of movement and dynamism.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
KJ Meditech Company, Limited C/O Ms. Priscilla Chung Regulatory Affairs Consultant LK Consulting Group 951 Starbuck Street, Unit J Fullerton, California 92833
JUN - 9 2011
Re: K103019
Trade/Device Name: KJ Mask Regulation Number: 21 CFR 872.5500 Regulation Name: Extraoral Orthodontic Headgear Regulatory Class: II Product Code: DZB Dated: May 31, 2011 Received: June 3, 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 approval 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 manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however. 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 concerning your device in the Federal Register.
3
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 /ucm115809.htm 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Wh 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
4
Indications for Use
103619 510(k) Number (if known):
Device Name: KJ Mask
Indications For Use:
KJ Mask is used as a treatment option for Class III malocclusions.
Prescription Use ど (Per 21 CFR 801 Subpart D)
AND
Over-The Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEE DED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
| 510(k) Number: | K103019 |
|---|---|
| ---------------- | --------- |