ALLURE MB CERAMIC BRACKETS

K090454 · Dentsply Interntional · NJM · Mar 20, 2009 · Dental

Device Facts

• Record ID: K090454
• Device Name: ALLURE MB CERAMIC BRACKETS
• Applicant: Dentsply Interntional
• Product Code: NJM · Dental
• Decision Date: Mar 20, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.5470
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Allure® MB ceramic brackets are indicated for the orthodontic movement of natural teeth, excluding mandibular bicuspid teeth.

Device Story

Allure® MB Ceramic Brackets are orthodontic appliances used to facilitate tooth movement. The device is a modification of the predicate Allure® (K852179), replacing a chemically treated base with a mechanical lock base. The new base incorporates rhomboid and 'torque-in-the-base' features to improve retention. The brackets are applied to teeth by an orthodontist or dental professional in a clinical setting. The mechanical lock design provides the necessary interface for bonding to the tooth surface, allowing the application of orthodontic forces to achieve desired tooth alignment. The device benefits patients by providing a ceramic aesthetic option for orthodontic treatment.

Clinical Evidence

No clinical data. The device relies on the established safety profile of materials used in legally marketed predicate devices.

Technological Characteristics

Ceramic orthodontic brackets featuring a mechanical lock base with rhomboid and 'torque-in-the-base' geometry. Materials are identical to those in predicate devices previously cleared for dental use.

Indications for Use

Indicated for orthodontic movement of natural teeth, excluding mandibular bicuspid teeth.

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

• Allure (K852179)
• Mystique MB Ceramic Brackets (K082974)

Submission Summary (Full Text)

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K090454

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## 510(k) SUMMARY for Allure® MB Ceramic Brackets

### DENTSPLY Internation

World Headquarters Susquehanna Commerce ( 221 West Philadelphia Sh York, PA 17405-0872 1800) 877-0020 Fax [phone] www.dentsply.com

- 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 |

19 February 2009 Date Prepared:

#### 2.. Device Name:

.

- Proprietary Name: Allure® MB Ceramic Brackets .
- Classification Name:
- Bracker, Ceramic, Orthodontic 872.5470
- CFR Number: . Device Class: .
- II NJM Product Code: .

#### ここ Sponsor's Predicate Device:

| Company | Device | 510(k) Number | Date Cleared |
|------------------------|---------------------------------|---------------|--------------|
| DENTSPLY International | Allure | K852179 | 08/20/1985 |
| DENTSPLY International | Mystique MB<br>Ceramic Brackets | K082974 | 11/07/2008 |

### Description of Device: 4.

The marketed product Allure® has a chemically treated base. A modification has been made to replace that base with a new mechanical lock base, Allure® MB. The mechanical lock base includes rhomboid and "torque-in-the-base" features.

- 5. Indications for Use:
Allure® MB Ceramic Brackets and Mystique MB Ceramic Brackets are indicated for orthodontic movement of natural teeth excluding mandibular bicuspid teeth.

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- Description of Safety and Substantial Equivalence: 6.
Technological Characteristics. Technological Characteristiss:
The Allure® MB Ceramic Brackets represent a modification to K852179.

All of the components found in Allure® MB Ceramic Brackets have been used in All of the components found in Anares most me safe for dental use. Allure® MB
legally marketed devices and/or were tound safe for dental wissess of therefor legally markets are the same composition as the predicate devices. Therefore, further biocompatibility testing is not necessary.

We believe that the prior use of the component of Allure® MB Ceramic Brackets we believe that the prof use of the componsible , and the provided, and the previously
in legally marketed devices, the performance data provided, and in legally marketed devices, the provide support regarding the safety and submitted blocompationity data each as exceets for the indicated uses.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure.

### Public Health Service

MAR 2 0 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K090454

> Trade/Device Name: Allure® MB Ceramic Brackets Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: II Product Code: NJM Dated: February 19, 2009 Received: February 23, 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 such additional controls. Existing major regulations affecting vour 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 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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 Barry
Ginette Y. Michaud, M.D.

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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# INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

K090454

Device Name: Allure® MB Ceramic Brackets

Indications for Use:

Allure® MB ceramic brackets are indicated for the orthodontic movement of natural teeth, excluding mandibular bicuspid teeth.

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)

Susan Reusser

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

510(k) Number: K0920454

Allure® MB Ceramic Brackets