(113 days)
Nitom Facebow Ortho Kinetics
Not Found
No
The summary describes a mechanical orthodontic device and does not mention any AI or ML components or functionalities.
Yes
The device is used in the "treatment of patients with Class III malocclusion." The term "treatment" indicates a therapeutic purpose.
No
The device description states it is an "orthodontic headgear device" used in the "treatment of patients with Class III malocclusion." Its purpose is therapeutic (treatment), not diagnostic (identifying a condition).
No
The device description explicitly states it is an "orthodontic headgear device" and mentions "All components," indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of patients with Class III malocclusion and anterior bite tendency, which is a therapeutic application, not a diagnostic one.
- Device Description: The description clearly states it's an "orthodontic headgear device," which is a physical appliance used to apply force to teeth and bones.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting substances, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Keles Facemask is intended for the treatment of patients with Class III malocclusions
The Keles protraction face mask is used in the treatment of patients with Class III malocclusions characterized by a retruded maxilla. The facemask is especially useful in patients with an anterior bite tendency or condition.
Product codes (comma separated list FDA assigned to the subject device)
DZB
Device Description
The Keles Facemask is an orthodontic headgear device. All components have been used in legally marketed devices or have been found to be safe for dental use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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.
Nitom Facebow Ortho Kinetics
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
K04/7/8
OCT 5 2004
Image /page/0/Picture/2 description: The image is a logo for Great Lakes Orthodontics. The logo features a black and white image of the United States with the Great Lakes highlighted in white. The words "GREAT LAKES" are written in a semi-circle above the image, and the word "ORTHODONTICS" is written in a semi-circle below the image. There are two dots on either side of the image.
Great Lakes Orthodontics, LTD.
An Employee Owned Company
Our Vision "Delight our customers. Respect and help our co-workers."
510(k) SUMMARY
CONTACT PERSON: Mr. David Graver Great Lakes Orthodontics 800-828-7626 dgraver@greatlakesortho.com
DATE PREPARED: June 23, 2004
TRADE OR PROPRIETARY NAME: Keles facemask COMMON NAME: Protraction Facemask CLASSIFICATION NAME: Orthodontic Extraoral Headgear 872.5500 PRODUCT CODE: DZB
PREDICATE DEVICE: Nitom Facebow Ortho Kinetics 1611A South Melrose Dr. Vista, CA 92083
DEVICE DESCRIPTION
The Keles Facemask is an orthodontic headgear device. All components have been used in legally marketed devices or have been found to be safe for dental use.
INTENDED USE The Keles Facemask is intended for the treatment of patients with Class III malocclusions
TECHNOLOGICAL CHARACTERISTICS COMPARED WITH PREDICATE DEVICE The Keles Facemask and predicate consists of similar extraoral and intraoral components.
We conclude that the similarity in design between the Keles Facemask and the predicate device supports the safety and effectiveness of the Keles Facemask for the indicated uses.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three horizontal lines curving upwards, with a wavy line underneath them.
OCT 15 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. David Graver Manager Great Lakes Orthodontics, Limited 200 Cooper Avenue P.O. Box 5111 Tonawanda, New York 14151-5111
Re: K041718
Trade/Device Name: Keles Facemask Regulation Number: 872.5500 Regulation Name: Extraoral Orthodontic Head Regulatory Class: II Product Code: DZB Dated: June 23, 2004 Received: July 19, 2004
Dear Mr. Graver:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 Nr.), it ind) 0 of 520 of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Eederal Register.
2
Page 2 - Mr. Graver
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. or the 100 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Susan Cunn
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Keles Facemask
Indications for Use
510(k) Number (if known): K041716
Great Lakes Orthodontics 200 Cooper Avenue Tonawanda, NY 14150
Device Name: Keles Facemask
Indications for Use:
The Keles protraction face mask is used in the treatment of patients with Class III The Keles profitaction facc mask is used in the neationed maxilla. The facemask is especially useful in patients with an anterior bite tendency or condition.
Prescription Use v
AND/OR
Over-The-Counter Use
(21 CFR Part 801 Subpart D)
(21 CFR Part 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Rupp
(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital,
Division Of Anesthesiology, General Devices Division of Ancolnoon Dental Devices
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