BRACE EZE

K020009 · Udent, Inc. · EGD · Feb 11, 2002 · Dental

Device Facts

• Record ID: K020009
• Device Name: BRACE EZE
• Applicant: Udent, Inc.
• Product Code: EGD · Dental
• Decision Date: Feb 11, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6890
• Device Class: Class 1
• Attributes: Therapeutic

Indications for Use

The intended use of Brace Eze is as a setting gel, which provides relief of the discomfort and irritation caused by orthodontic braces to the inside of the cheek and lips.

Device Story

Brace Eze is an orally applied gel designed for application to orthodontic brackets. It functions as a protective barrier to alleviate discomfort and irritation caused by braces rubbing against the inside of the cheek and lips. The device is intended for over-the-counter use by patients. By providing a smooth surface over the brackets, it reduces mechanical irritation, potentially improving patient comfort during orthodontic treatment.

Technological Characteristics

Orally applied gel. No specific materials, energy sources, or software components described.

Indications for Use

Indicated for relief of discomfort and irritation to the inside of the cheek and lips caused by orthodontic braces in patients undergoing orthodontic treatment.

Regulatory Classification

Identification

Intraoral dental wax is a device made of wax intended to construct patterns from which custom made metal dental prostheses, such as crowns and bridges, are cast. In orthodontic dentistry, the device is intended to make a pattern of a patient's bite to make study models of the teeth.

Predicate Devices

• Ortho Wax (K924024)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows a logo with the letters "UNT" in a stylized font. Below the logo, the words "Dentistry has a Homepage" are written in a smaller font. The logo and text are in black and white.

FEB 1 1 2002

UDENT, INC. P.O. Box 58 Chino Hills. CA 91709 Phone: [phone] Fax: [phone] Email: [e-mail]

KU20009

## Chapter 8 - 510(k) Summary

Submitter:

UDENT, Inc. 676 Fairplex Drive Pomona, CA 91768 Phone: [phone] Fax: [phone] Contact: Manar M. Jamal, DDS Email: [e-mail]

Date of Submission: December 28, 2001

### Device Name:

Trade name: Common name: Classification name:

Brace Eze Orthodontic brace irritation relief Orthodontic: Appliance & Accessories (per 21 CFR section 880.6250)

#### Description of Device:

Brace Eze is an orally applied gel that is applied to the brackets of orthodontic braces.

### The Intended Use of Device:

The intended use of Brace Eze is as a setting gel, which provides relief of the discomfort and irritation caused by orthodontic braces to the inside of the cheek and lips.

### Device for Which Substantial Equivalence is Claimed:

Ortho Wax

### Substantial Equivalence:

Brace Eze is substantial equivalent to other legally marketed devices in the United States. Brace Eze functions in a manner similar to and is intended for the same use as Ortho Wax cleared for marketing for Heraeus Kulzer, Inc (K924024).

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Image /page/1/Picture/1 description: The image is a black and white circular seal. The seal contains the symbol of the United States Department of Health and Human Services, which is an abstract image of an eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 1 2002

Dr. Manar M. Jamal President UDENT, Incorpoated 676 Fairplex Drive Pomona, California 91768

Re: K020009

Trade/Device Name: Brace Eze Regulation Number: 872.6890 Regulation Name: Intraoral Dental Wax Regulatory Class: I Product Code: EGD Dated: December 28, 2001 Received: January 02, 2002

Dear Dr. Jamal:

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 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.

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.

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You must comply with all the Act's requirements, including, but not limited to: registration r od intest comply with and any labeling (21 CFR Part 801); good manufacturing practice and ilsuing (21 OF RT Lev (0)); in the quality systems (QS) regulation (21 CFR Part 820); and if requirences as bet form nroduct 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 I ins least will and w you to over and A 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 If you desire up 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and Office of Configitance are, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and the receint of to verailirs toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Timoth Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Chapter 15 - Indications For Use

510(k) Number: K020009

Device Name: Brace Eze

Indications For Use:

Brace Eze is intended to provide relief from the discomfort and irritation to the inside of the cheek and lips caused by orthodontic brace.

Over-the-Counter Use

Siver Russer

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices NOO 510(k) Number _