PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION II

K093221 · Dentsply Intl., Inc. · DYH · Oct 30, 2009 · Dental

Device Facts

• Record ID: K093221
• Device Name: PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION II
• Applicant: Dentsply Intl., Inc.
• Product Code: DYH · Dental
• Decision Date: Oct 30, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3750
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

System consists of pre-cemented ceramic and metal orthodontic brackets, transfer tray, and adhesives. Used by orthodontists in clinical settings to bond appliances to teeth for orthodontic treatment. Device functions as a delivery system for pre-applied adhesive to facilitate efficient bracket placement. No new technological changes to the super mesh base compared to predicate systems; no additional shear bond strength or biocompatibility testing required.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on the use of components previously cleared for dental use and the absence of design changes to the bracket base.

Technological Characteristics

System includes ceramic and metal orthodontic brackets, transfer tray, and adhesives. Features a super mesh base design consistent with predicate devices. Class II device under 21 CFR 872.3750.

Indications for Use

Indicated for patients requiring orthodontic treatment involving the bonding of orthodontic appliances.

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)
• Pre-Cemented Orthodontic Bracket System Extension (K081291)

Submission Summary (Full Text)

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K093221

OCT 3 0 2009

Image /page/0/Picture/1 description: The image shows the word "DENTSPLY" in a bold, sans-serif font. The letters are all capitalized and black. The letters are closely spaced together, and the overall effect is one of solidity and strength.

### 510(k) SUMMARY for

# Pre-Cemented Orthodontic Bracket system Extension II

## 06. Submitter Information:

DENTSPLY International Susquehanna Commerce Center 221 West Philadelphia Street York, PA 17405

| Contact Person: | Helen Lewis |
|-------------------|--------------|
| Telephone Number: | 717-849-4229 |
| Fax Number: | 717-849-4343 |

Date Prepared: 7 October 2009

#### 2. Device Name:

- Pre-Cemented Orthodontic Bracket System Proprietary Name: .
- Extension II Adhesive, bracket and tooth conditioner, . Classification Name:
- resin CFR Number: 872.3750 .
- Device Class: II .
- DYH Product Code: .
- Sponsor's Predicate Device: నా

| Company | Device | 510(k) Number | Date Cleared |
|------------------------------|------------------------------------------------------|---------------|--------------|
| DENTSPLY International, Inc. | Pre-Cemented Orthodontic<br>Bracket System | K061252 | 02/12/2007 |
| DENTSPLY International, Inc. | Pre-Cemented Orthodontic<br>Bracket System Extension | K081291 | 05/22/2008 |

- Description of Device: 4.
The Pre-Cemented Orthodontic Bracket System Extension II is comprised of precemented ceramic and metal orthodontic brackets, transfer tray and adhesives.

- 5. Indications for Use:
Pre-Cemented Orthodontic Bracket System Extension II is indicated for use in bonding orthodontic appliances for orthodontic treatment.

### DENTSPLY International

World Headquarters Susquehanna Commerce Center 221 West Philadelphia Street York, PA 17405-0872 [phone] Fax [phone] www.dentsply.com

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#### Description of Safety and Substantial Equivalence: 6.

Technological Characteristics.

The Pre-Cemented Orthodontic Bracket System Extension II represents an addition of K081291.

All of the components found in the Pre-Cemented Orthodontic Bracket System Extension II have been used in legally marketed devices and/or were found safe for dental use. Since there is no change in the super mesh base for both the metal and ceramic brackets, shear bond strength testing, Failure Mode Effect Analysis (FMEA) and biocompatibility testing was not necessary.

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

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of a human figure embracing a three-tiered sphere, which is meant to represent the department's mission of protecting the health of all Americans and providing essential human services.

### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

## OCT 3 0 2009

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

Re: K093221

Trade/Device Name: Pre-Cemented Orthodontic Bracket System Extension II Regulation Number: 21 CFR 872.3750 Regulation Name: Bracket Adhesive Resin and Tooth Conditioner Regulatory Class: II Product Codes: DYH, NJM, and EJF Dated: October 7, 2009 Received: October 13, 2009

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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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 vours,

for

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

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### INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

Device Name: Pre-Cemented Orthodontic Bracket System Extension II

Indications for Use:

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

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

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kain Moley fn MSP

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

. 510(k) Number: K093221