GENERATION C AESTHETIC SELF-LIGATING BRACKET SYSTEM

K112707 · Ortho Technology, Inc. · NJM · Jan 13, 2012 · Dental

Device Facts

• Record ID: K112707
• Device Name: GENERATION C AESTHETIC SELF-LIGATING BRACKET SYSTEM
• Applicant: Ortho Technology, Inc.
• Product Code: NJM · Dental
• Decision Date: Jan 13, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5470
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Generation CTM Aesthetic Self-Ligating Bracket System indication for use is to correct malocclusions of the teeth as determined by a licensed Orthodontist/Dentist. The brackets are intended to only be bonded to natural teeth. The brackets are used with orthodonic wire to control the direction of the tooth movement of the individual teeth by providing a slow and continuous force to the teath slow and continuous force to the teeth.

Device Story

Generation C™ Aesthetic Self-Ligating Bracket System; orthodontic device for malocclusion correction. Brackets bond to natural teeth; used with orthodontic wires to apply slow, continuous force for controlled tooth movement. Operated by licensed orthodontists/dentists in clinical settings. System facilitates tooth alignment; benefits patient through aesthetic correction of dental malocclusions.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Aesthetic self-ligating orthodontic bracket system. Materials: Plastic. Principle: Mechanical force application via orthodontic wire. Form factor: Bracket system for bonding to natural teeth. Non-electronic; no software.

Indications for Use

Indicated for correction of malocclusions in patients requiring orthodontic treatment, as determined by a licensed orthodontist or dentist. Brackets are bonded to natural teeth and used with orthodontic wire to provide force for tooth movement.

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.

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

JAN 1 3 2012

Ms. Jodi Hutchins Quality Assurance/Regulatory Affairs Director Ortho Technology, Incorporated 17401 Commerce Park Boulevard Tampa, Florida 33647

Re: K112707

Trade/Device Name: Generation C'™ Aesthetic Self-Ligating Bracket System Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: II Product Code: NJM Dated: December 22, 2011 Received: December 23, 2011

Dear Ms. Hutchins:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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. Hutchins

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/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm 1 15809.htm 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/MedicalDevices/Safety/ReportaProblem /default.htm 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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Wh for

Anthony D. Watson, B.S., M.S., M.B.A. 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: _ K112707

Device Name: Generation CTM Aesthetic Self-Ligating Bracket System

Indications for Use:

Generation CTM Aesthetic Self-Ligating Bracket System indication for use is to correct malocclusions of the teeth as determined by a licensed Orthodontist/Dentist. The brackets are intended to only be bonded to natural teeth. The brackets are used with orthodonic wire to control the direction of the tooth movement of the individual teeth by providing a
slow and continuous force to the teath slow and continuous force to the teeth.

Prescription Use X (Pert 21 CFR 801 Subpart D)

and/or

Over –The Counter Use No (Per 21 CFR 801 Subpart C)

Concurrence of CDHR, Office of Device Evaluation (ODE)

C
(Division Sign Off)

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

510(k) Number: K112707