PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION

K081291 · Dentsply Interntional · DYH · May 22, 2008 · Dental

Device Facts

• Record ID: K081291
• Device Name: PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION
• Applicant: Dentsply Interntional
• Product Code: DYH · Dental
• Decision Date: May 22, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3750
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Pre-Cemented Orthodontic Bracket System Extension is intended for use in bonding orthodontic appliances for orthodontic treatment.

Device Story

System consists of pre-cemented ceramic and metal orthodontic brackets and transfer tray; used for bonding orthodontic appliances to teeth. Modification adds a second ceramic bracket to existing system. Components are identical to predicate devices (K061252, K060837). Used by orthodontists in clinical settings to facilitate bracket placement during treatment. System utilizes pre-applied adhesive to simplify bonding process; benefits include standardized application and reduced chair time.

Clinical Evidence

No clinical data. Substantial equivalence is based on bench testing and the use of materials previously cleared for dental use in predicate devices.

Technological Characteristics

System includes ceramic and metal orthodontic brackets, transfer tray, and adhesive resin. Materials are identical to those in K061252 and K060837. Device is classified as a surface-contacting device with permanent contact. No changes in formulation from predicates.

Indications for Use

Indicated for bonding orthodontic appliances for orthodontic treatment in patients requiring such therapy.

Regulatory Classification

Identification

A bracket adhesive resin and tooth conditioner is a device composed of an adhesive compound, such as polymethylmethacrylate, intended to cement an orthodontic bracket to a tooth surface.

Predicate Devices

• Pre-Cemented Orthodontic Bracket System (K061252)
• In-Ovation™ C (K060837)

Submission Summary (Full Text)

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## 510(k) SUMMARY

K081291

DENTSPLY International Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York, PA 17405-0872

| CONTACT: | Helen Lewis | |
|----------------------------|--------------------------------------------------------------------------|-------------|
| DATE PREPARED: | May 5, 2008 | MAY 22 2008 |
| TRADE OR PROPRIETARY NAME: | Pre-Cemented Orthodontic Bracket System Extension | |
| CLASSIFICATION NAME: | Bracket adhesive resin and tooth conditioner | |
| CFR NUMBER: | 872.3750 | |
| DEVICE CLASS: | II | |
| PRODUCT CODE: | DYH | |
| PREDICATE DEVICES: | Pre-Cemented Orthodontic Bracket System, K061252 In-Ovation™ C, K060837. | |

DEVICE DESCRIPTION: The Pre-Cemented Orthodontic Bracket System Extension is comprised of pre-cemented ceramic and metal orthodontic brackets, transfer tray, and the adhesives described in K061252. Components of this system are used exactly as described in K061252 (Pre-cemented Orthodontic Bracket System) with the same fundamental technology and for the same intended use. This modification adds a second ceramic orthodontic bracket to the Pre-cemented Orthodontic Bracket System (K060837).

INTENDED USE: The Pre-Cemented Orthodontic Bracket System Extension is intended for use in bonding orthodontic appliances for orthodontic treatment.

TECHNOLOGICAL CHARACTERISTICS: The Pre-Cemented Orthodontic Bracket System Extension represents a modification to K061252.

All of the components found in the Pre-Cemented Orthodontic Bracket System Extension have been used in legally marketed devices and/or were found safe for dental use. The Pre-Cemented Orthodontic Bracket System Extension has been evaluated and passed biocompatibility testing for devices classified as surface-contacting devices with permanent contact. As there are no changes in formulation from the predicate devices (K060837 and K061252), we believe that no additional biocompatibility testing is required.

We believe that the prior use of the components of Pre-Cemented Orthodontic Bracket System Extension in legally marketed devices, the previous biocompatibility data, and the performance date provided support the safety and effectiveness of the Pre-Cemented Orthodontic Bracket Systension for the indicated uses.

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 2 2008

Ms. Helen Lewis Director of Corporate Compliance and Regulatory Affairs DENTSPLY International, Incorporated Susquehanna Commerce Center 221 West Philadelphia Street, Suite 60 York, Pennsylvania 17405-0872

Re: K081291

Trade/Device Name: Pre-Cemented Orthodontic Bracket System Extension Regulation Number: 872.3750 Regulation Name: Bracket Adhesive Resin and Tooth Conditioner Regulatory Class: II Product Code: DYH, NJM, EJF Dated: May 5, 2008 Received: May 7, 2008

Dear Ms. Lewis:

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.

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Page 2- Ms. Lewis

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 (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" (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.

Sincercly yours,

Sayite Y. Michaud md.

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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## Indications for Use

## 510(k) Number (if known): K081291

Device Name: Pre-Cemented Orthodontic Bracket System Extension

## Indications for Use:

The Pre-Cemented Orthodontic Bracket System Extension is indicated for use in bonding orthodontic appliances for orthodontic treatment.

Prescription Use × (21 CFR Part 801 Subpart D) AND/OR

Over-The-Counter Use (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)

Sven Puma

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

1 -101 510(k) Number:

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