BERNHARD-FORSTER GMBH ORTHODONTIC CERAMIC BRACKETS

K090933 · Forestadent Bernhard Forster GmbH · NJM · Jun 5, 2009 · Dental

Device Facts

• Record ID: K090933
• Device Name: BERNHARD-FORSTER GMBH ORTHODONTIC CERAMIC BRACKETS
• Applicant: Forestadent Bernhard Forster GmbH
• Product Code: NJM · Dental
• Decision Date: Jun 5, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5470
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The device is intended for orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. The devices are intended to be single used only.

Device Story

Orthodontic ceramic brackets bonded to teeth; apply forces to teeth via flexible orthodontic wire to alter tooth position. Features aesthetic and self-ligating design to facilitate wire placement and removal. Used in clinical orthodontic settings by dental professionals. Benefits include tooth alignment and aesthetic improvement during treatment.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

High purity alumina ceramic material (ISO 6474:1994). Self-ligating design. Non-sterile. Standalone mechanical device.

Indications for Use

Indicated for orthodontic movement of teeth in patients requiring orthodontic treatment. Single use only.

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

• In-Ovation C (K060837)

Submission Summary (Full Text)

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# 133

JUN - 5 2009

Page 12

## 510(k) Summary of Safety & Effectiveness

in accordance with requirements 21 CFR 807.92.

## 1. Company

Bernhard Forster GmbH Westliche Karl- Friedrichstraße 151 75172 Pforzheim - Germany

| Telephone: | 049-7231-459-0 |
|------------|------------------|
| Fax: | 049-7231-459-102 |
| Contact: | Michael Fieß |

#### 2. Device

Orthodontic Ceramic Brackets Proprietary - trade name : Bracket, Ceramic, Orthodontic, product code NJM Classification name:

#### 3. Equivalent legally marketed devices:

Orthodontic Ceramic Bracket Innovation C (K060837), Dentsply International

#### 4. Indication for use:

The device is intended for orthodontic movement of theth. It is used temporarily and is removed after orthodontic treatment has been completed. The devices are intended to be single used only.

#### 5. Description of the device

The Orthodontic Ceramic Brackets are bonded to tecth to apply forces to the tooth, transmitted through a flexible orthodontic wire , to alter the tooth position. The ceramic bracket has both, aesthetic and self ligating qualities. This aimed at facilitating easier orthodontic wire placement and removal through self- ligatation

The function and performance of the orthodontic ceramic brackets are equal to the predicate device.

The Material was selected according the requirements of ISO 6474;1994. Ceramic materials based on High purity aluminia.

| Device name | In- Ovation C<br>Dentsply | Bernhard Forster GmbH<br>Orthodontic Ceramic brackets |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>classification<br>name | Orthodontic Ceramic Bracket<br>CFR 872.5470, NJM | Orthodontic Ceramic bracket CFR 872.5470; NJM |
| Applicant | Dentsply International | Bernhard Forster GmbH |
| 510(k) - Number | (K060837) | This submission |
| Material | A1203 | ALSO3 |
| Intended use | The innovation C is intended<br>for orthodontic movement of<br>natural teeth , excluding the<br>mandibular bicuspid teeth . | The device is intended for orthodontic movement of teeth.<br>It is used temporarily and is removed after orthodontic<br>treatment has been completed. The devices are intended to<br>be single used only. |
| Single use? | YES | YES |
| Sterility | Non-sterile | Non-sterile |

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular fashion around the eagle. The eagle is depicted in black and white, and the text is also in black.

### Public Health Service

JUN - 5 2009

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Michael Fieb Regulatory Affairs Manager Forestadent Bernhard Förster GmbH Westliche Karl- Friedrich-Straße 151 75172 Pforzheim GERMANY

Re: K090933

Trade/Device Name: Orthodontic Ceramic Brackets Regulation Number: 21.CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: II Product Code: NJM Dated: March 31, 2009 Received: April 2, 2009

Dear Mr. Fieb:

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 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.

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## Page 2- Mr. Fieb

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/cdrh/comp/ 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/cdrh/mdr/ 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Susan Penney

Susan Runner, D.D.S., M.A. Acting 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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K090933

# 4. Indications for Use

510(k) Number (if known):

## Device Name: Orthodontic Ceramic Brackets

Indications For Use: The device is intended for orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. The devices are intended to be single used only.

Prescription Use X (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)

Lei Mulvey for MSR

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

510(k) Number: K090933