GC KommonBase

K143667 · Gc Orthodontics America, Inc. · DYH · May 7, 2015 · Dental

Device Facts

• Record ID: K143667
• Device Name: GC KommonBase
• Applicant: Gc Orthodontics America, Inc.
• Product Code: DYH · Dental
• Decision Date: May 7, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3750
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Fabricating resin base (understructure) for bracket placement

Device Story

GC KommonBase is a dental material used by orthodontists to fabricate a resin base or understructure to facilitate the placement of orthodontic brackets. The device is applied chairside by a dental professional to create a custom base that improves the fit and bonding of brackets to the tooth surface. It functions as a restorative/orthodontic adhesive component, aiding in the clinical workflow of fixed appliance therapy.

Clinical Evidence

Bench testing only.

Technological Characteristics

Resin-based dental material for orthodontic bracket understructure fabrication. Classified under 21 CFR 872.3750 (Bracket Adhesive and Tooth Conditioner).

Indications for Use

Indicated for the fabrication of resin bases (understructures) for orthodontic bracket placement.

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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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them.

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

May 7, 2015

GC Orthodontics America, Inc. c/o Mark Heiss, DDS GC America, Inc. 3737 W. 127th Street Alsip, IL 60803

Re: K143667

Trade/Device Name: GC KommonBase Regulation Number: 21 CFR 872.3750 Regulation Name: Bracket Adhesive and Tooth Conditioner Regulatory Class: II Product Codes: DYH Dated: February 6, 2015 Received: February 12, 2015

Dear Dr. Heiss:

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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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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

Tina
Kiang -S

for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Section 4 - Indications for Use Statement

Indications for Use

510(k) Number (if known): K143667

Device Name: GC KommonBase

Indications for Use:

Fabricating resin base (understructure) for bracket placement

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)