ORTHODONTIC FLOWABLE BRACKET ADHESIVE

K120619 · Novocol, Inc. · DYH · May 21, 2012 · Dental

Device Facts

• Record ID: K120619
• Device Name: ORTHODONTIC FLOWABLE BRACKET ADHESIVE
• Applicant: Novocol, Inc.
• Product Code: DYH · Dental
• Decision Date: May 21, 2012
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.3750
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Orthodontic Flowable Bracket Adhesive is a light cured composite designed for use in the indirect bonding technique and with lingual retainers, archwire stops, and Invisalign® attachments. It can also be used for occlusal build-ups. Its low viscosity and precise syringe delivery make it easy to place and finish, and adaptable to a variety of clinical situations.

Device Story

Orthodontic Flowable Bracket Adhesive is a light-cured composite resin used by orthodontists in clinical settings. The device is supplied in a syringe for precise delivery to the tooth surface or orthodontic appliance. It functions as a bonding agent for indirect bonding, lingual retainers, archwire stops, and Invisalign® attachments, or as a material for occlusal build-ups. The low-viscosity formulation allows for easy placement and finishing. The clinician applies the material, which is then cured using a dental light source to achieve the desired bond or structural build-up. This facilitates orthodontic treatment by securing attachments or modifying occlusal surfaces.

Clinical Evidence

Bench testing only.

Technological Characteristics

Light-cured composite resin; low-viscosity formulation; syringe delivery system; class II medical device (21 CFR 872.3750).

Indications for Use

Indicated for orthodontic patients requiring indirect bonding, lingual retainers, archwire stops, Invisalign® attachments, or occlusal build-ups.

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.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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#### Public Health Service

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

Mr. Steven Rudolph Director of Operations Novocol, Inc. 416 South Taylor Avenue Louisville, Colorado 80027

MAY 2 1 2012

Re: K120619

Trade/Device Name: Orthodontic Flowable Bracket Adhesive Regulation Number: 21 CFR 872.3750 Regulation Name: Bracket Adhesive Resin and Tooth Conditioner Regulatory Class: II Product Code: DYH Dated: May 14, 2012 Received: May 16, 2012

Dear Mr. Rudolph:

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 - Mr. Ruldolph

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 /ucm115809.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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Rh

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 Statement

510(k) Number: K120619

Device Name: Orthodontic Flowable Bracket Adhesive

Indications for Use:

Orthodontic Flowable Bracket Adhesive is a light cured composite designed for use in the indirect bonding technique and with lingual retainers, archwire stops, and Invisalign® attachments. It can also be used for occlusal build-ups. Its low viscosity and precise syringe delivery make it easy to place and finish, and adaptable to a variety of clinical situations.

Prescription Use × (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)

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510(k) Nu ::

K120619

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