RED, WHITE & BLUE

K040874 · Allesee Orthodontic Appliances · NXC · Jun 18, 2004 · Dental

Device Facts

• Record ID: K040874
• Device Name: RED, WHITE & BLUE
• Applicant: Allesee Orthodontic Appliances
• Product Code: NXC · Dental
• Decision Date: Jun 18, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5470
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The intended use of Red, White & Blue is to correct minor to intermediato anterior tooth malalignments in patients with permanent dentition (second molars) by moving tecth progressively through the use of three, clear, lightwoight, plastic retainers.

Device Story

Red, White & Blue is a series of three clear, lightweight plastic retainers used to correct minor to intermediate anterior tooth mal-alignments. The dental practitioner takes impressions of the patient's teeth and selects anterior teeth for repositioning. Impressions or models are sent to the manufacturer (AOA) with a prescription. AOA technicians cut the selected teeth from the model and progressively reposition them; three corresponding appliances are fabricated to move teeth incrementally toward a final treated state. The retainers are mailed to the practitioner, who provides them to the patient. The system serves as an aesthetic alternative to conventional wire and bracket orthodontics. It is used in a clinical setting under the guidance of a dental practitioner to achieve progressive tooth movement.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

System consists of three clear, lightweight plastic retainers. The device is a preformed tooth positioner (21 CFR 872.5525). It functions via mechanical force applied by the plastic appliances to reposition anterior teeth. No electronic components, software, or energy sources are involved.

Indications for Use

Indicated for patients with permanent dentition (second molars) requiring correction of minor to intermediate anterior tooth mal-alignments.

Regulatory Classification

Identification

An orthodontic plastic bracket is a plastic device intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position.

Predicate Devices

• Align Technology, Invisalign

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other.

## JAN 2 6 2006

Allesee Orthodontic Appliances, Incorporated C/O Ms. Colleen Boswell Director, Corporate Compliance Sybron Dental Specialties, Incorporated 1717 West Collins Avenue Orange, California 92867

Re: K040874

Trade/Device Name: Red, White, & Blue Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: II Product Code: NXC Dated: March 31, 2004 Received: April 02, 2004

Dear Ms. Boswell:

This letter corrects our substantially equivalent letter of June 18, 2004.

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 (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 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.

Image /page/0/Picture/10 description: The image is a circular logo for the FDA Centennial. The logo features the letters "FDA" in a bold, sans-serif font in the center. Above the letters, the years "1906 - 2006" are displayed. Below the letters, the word "Centennial" is written in a cursive font. The entire logo is surrounded by a circular border with text that is difficult to read due to the image quality.

*Protecting and Promoting Public Health*

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville, Maryland 20850

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#### Page 2 - Ms. Colleen Boswell

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); good manufacturing practice requirements as set forth in the quality systems (OS) 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 continue 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" (21 CFR 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/industry/support/index.html

Sincerely yours.

Janette y. Michie Ows.

Chiu S. Lin, PhD 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):

K040874

Device Name: Red, White & Blue

Indications For Use:

Red, White & Blue is a series of three, clear, lightwelght, plastic retainers intended to be used to correct minor to internediate anterior tooth mal-alignments in patients with permanent dentition (second molars) by moving teeth progressively to a final, treated state.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Suren Runner

(Division Sign-Off) Division of Anesthesiology, General Hospit Infection Control, Dental Devices

510(k) Number. K640

Page 1 of 1

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Ko40874

Section 111 - 510(k) Summary of Safety and Effectiveness

## Submitter:

Allesee Orthodontic Appliances, Inc. 13931 Spring Street Sturtevant, WI 53177

#### Contact:

Colleen Boswell Sybron Dental Specialties, Inc. [phone] - Phone [phone] - Facsimile

Date Summary Prepared: June 2004

Device Name:

- Trade Name Red, White & Blue .
- Common Name Preformed Tooth Positioner .
- Classification Name -- Preformed Tooth Positioner, per 21 CFR § 872.5525 .

### Dovices for Which Substantial Equivalence is Claimed:

- Align Technology, Invisalign .
### Device Description:

Red, White & Blue is a relainer system which offers a solution to those patients who want a simple, aesthetic system to correct minor to intermediate tooth mal-alignments without the use of conventional wire and brucket orthodontic technology. The system consists of a scrics of three, clear lightweight, plastic retainers. Each appliance applics incremental tooth correction by means of repositioning the anterior teeth. In this way, the patient's tecth will get progressively closer to the desired final state.

The dental practitioner will make dental improssions of his patient's tecth and select the anterior tecth that are to be repositioned. The impressions or a model of the tecth made from the improssion is then sent to AOA along with a prescription form. The teeth selected for treatment are cut from the model and progressively repositioned. After each repositioning, AOA will create a corresponding appliance for a total of three active appliances. Depending upon the complexity of the case, it is possible that a patient may require less or more than the series of three appliances. The Red, White & Blue retainers are mailed to the dental

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practitioner, who in turn, will provide them to their patient with the instructions for use,

#### Intended Use of the Device:

The intended use of Red, White & Blue is to correct minor to intermediato anterior tooth malalignments in patients with permanent dentition (second molars) by moving tecth progressively through the use of three, clear, lightwoight, plastic retainers.

#### Substantial Equivalence:

Red, White & Blue is substantially equivalent to other legally marketed devices in the United States. Red, White & Blue is used in a manner similar to the Invisalign system marketed by Align Technology.