GC Ortho Connect, GC Ortho Etching Gel

K150128 · Gc Orthodontics America, Inc. · DYH · Jul 16, 2015 · Dental

Device Facts

• Record ID: K150128
• Device Name: GC Ortho Connect, GC Ortho Etching Gel
• Applicant: Gc Orthodontics America, Inc.
• Product Code: DYH · Dental
• Decision Date: Jul 16, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3750
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

GC Ortho Connect 1. Bonding metal brackets and attachments 2. Bonding ceramic brackets 3. Bonding plastic brackets and acrylic appliances GC Ortho Etching Gel 1. Etching enamel of tooth surfaces 2. Enhancing the bond strength of light-cured orthodontic adhesive materials

Device Story

GC Ortho Connect is a light-cured orthodontic adhesive resin; GC Ortho Etching Gel is a tooth conditioner. Used by orthodontists in clinical settings to bond orthodontic brackets (metal, ceramic, plastic) and acrylic appliances to tooth enamel. Etching gel prepares enamel surface to enhance bond strength. Adhesive is applied to bracket base, placed on tooth, and light-cured to secure attachment. Facilitates orthodontic treatment by providing stable bracket-to-tooth fixation.

Clinical Evidence

bench testing only

Technological Characteristics

GC Ortho Connect is a light-cured resin adhesive; GC Ortho Etching Gel is a phosphoric acid-based tooth conditioner. Classified under 21 CFR 872.3750, Product Code DYH. No specific material standards or software components described.

Indications for Use

Indicated for orthodontic patients requiring bonding of metal, ceramic, or plastic brackets and acrylic appliances to tooth enamel, and for etching enamel to improve bond strength of light-cured adhesives.

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

July 16, 2015

GC Orthodontics America Inc. Dr. Mark Heiss Director, Regulatory Affairs & Professional Relations 11535 S Central Avenue Alsip, IL 60803

Re: K150128

Trade/Device Name: GC Ortho Connect, GC Ortho Etching Gel Regulation Number: 21 CFR 872.3750 Regulation Name: Bracket adhesive resin and tooth conditioner Regulatory Class: II Product Code: DYH Dated: April 17, 2015 Received: April 20, 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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Page 2 - Dr. Mark Heiss

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/Resourcesfor You/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): _K150128

Device Name: GC Ortho Connect and GC Ortho Etching Gel

Indications for Use:

GC Ortho Connect

- 1. Bonding metal brackets and attachments
- 2. Bonding ceramic brackets
- 3. Bonding plastic brackets and acrylic appliances

## GC Ortho Etching Gel

- 1. Etching enamel of tooth surfaces
- 2. Enhancing the bond strength of light-cured orthodontic adhesive materials

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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