IN-OVATION C

K060837 · Dentsply International · NJM · Apr 10, 2006 · Dental

Device Facts

• Record ID: K060837
• Device Name: IN-OVATION C
• Applicant: Dentsply International
• Product Code: NJM · Dental
• Decision Date: Apr 10, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.5470
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

In-Ovation™ C is indicated for orthodontic movement of natural teeth, excluding the mandibular bicuspid teeth.

Device Story

In-Ovation™ C is a ceramic orthodontic bracket bonded to teeth; applies pressure to teeth via flexible orthodontic wire to alter tooth position. Features self-ligating mechanism to facilitate wire placement and removal; enhances bonding/debonding characteristics. Used by orthodontists in clinical settings. Benefits patient through aesthetic ceramic design and improved mechanical efficiency for tooth movement.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and design comparison to predicate.

Technological Characteristics

Ceramic orthodontic bracket; self-ligating design; materials previously used in legally marketed DENTSPLY devices. Mechanical function via wire-bracket interaction.

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

• Orthodontic Ceramic Brackets (Mystique®) (K042178)

Submission Summary (Full Text)

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APR 1 0 2006

DENTSPLY International World Headquarters Susquehanna Commerce Center 221 West Philadelphia Street York, PA 17405-0872

Helen Lewis CONTACT:

March 23, 2006 DATE PREPARED:

TRADE OR PROPRIETARY NAME:

In-Ovation™ C

Bracket, Ceramic, Orthodontic 21 CFR 872.5470 CLASSIFICATION NAME:

Orthodontic Ceramic Brackets (K042178) PREDICATE DEVICES:

DEVICE DESCRIPTION:

The In-Ovation™ C brackets are bonded to teeth to apply pressure to the tooth, transmitted through a flexible orthodontic wire, to alter the tooth position. The modified orthodontic ceramic bracket has both aesthetic and self-ligating qualities. The modifications were aimed at facilitating easier orthodontic wire placement and removal through self-ligation and enhancing the bonding and debonding characteristics of the bracket.

INTENDED USE:

The In-Ovation™ C is indicated for orthodontic movement of natural teeth, excluding the mandibular bicuspid teeth.

TECHNOLOGICAL CHARACTERISTICS:

The function and performance of the In-Ovation™ C bracket is similar to the predicate. Minor design changes and incorporation of self-ligation are the only modifications made to the Orthodontic Ceramic Brackets (Mystique®) (K042178).

There are no changes in the intended use and fundamental scientific technology. All of the materials used in the device have been used in legally marketed DENTSPLY devices. We believe that the modified device is substantially equivalent to the predicate Orthodontic Ceramic Brackets (Mystique®) (K042178).

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three intertwined lines forming a shape similar to a bird or a wave.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 0 2006

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

Re: K060837

Trade/Device Name: In-Ovation™ C Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: II Product Code: NJM Dated: March 24, 2006 Received: March 28, 2006

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. Helen 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.

Sincerely yours.

Chu S. Lin, PhD

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 STATEMENT

(As Required by 21 CFR 807.87(e)

| <strong>Labels</strong> | <strong>Values</strong> |
|---------------------------|-------------------------|
| 510(K) Number (if known): | 2060837 |

Device Name: In-Ovation™ C

Indications for Use:

In-Ovation™ C is indicated for 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 807 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Hai Malay for MSR

General Motors

K060837