KELES FACEMASK

K041718 · Great Lakes Orthodontics, Ltd. · DZB · Oct 15, 2004 · Dental

Device Facts

• Record ID: K041718
• Device Name: KELES FACEMASK
• Applicant: Great Lakes Orthodontics, Ltd.
• Product Code: DZB · Dental
• Decision Date: Oct 15, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Keles protraction face mask is used in the treatment of patients with Class III malocclusions and a retruded maxilla. The facemask is especially useful in patients with an anterior bite tendency or condition.

Device Story

Keles Facemask is an orthodontic extraoral headgear device; used for treatment of Class III malocclusions and retruded maxilla. Device applies mechanical force to the maxilla to correct skeletal discrepancies. Operated by orthodontic clinicians in a clinical setting. Provides external support structure for intraoral orthodontic appliances. Benefits patients by correcting jaw alignment and bite conditions.

Clinical Evidence

No clinical data provided; substantial equivalence based on design similarity and use of materials previously cleared for dental applications.

Technological Characteristics

Orthodontic extraoral headgear; consists of extraoral and intraoral components. Materials are those previously used in legally marketed dental devices. Mechanical operation.

Indications for Use

Indicated for patients with Class III malocclusions and retruded maxilla, particularly those with anterior bite tendency.

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.

Predicate Devices

• Nitom Facebow Ortho Kinetics (K013488)

Submission Summary (Full Text)

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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 [e-mail]

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.

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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.

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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 [phone]. 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 [phone] or [phone] 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

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#### 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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