ORTHODONTIC CERAMIC BRACKETS

K123094 · Tomy, Inc. · NJM · Dec 13, 2012 · Dental

Device Facts

• Record ID: K123094
• Device Name: ORTHODONTIC CERAMIC BRACKETS
• Applicant: Tomy, Inc.
• Product Code: NJM · Dental
• Decision Date: Dec 13, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5470
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ORTHODONTIC CERAMIC BRACKETS are indicated for orthodontic movement of natural teeth, excluding mandibular bicuspid teeth.

Device Story

Orthodontic ceramic brackets are bonded to natural teeth by dental professionals to facilitate tooth movement via connection to orthodontic wires. The device consists of a polycrystalline alumina ceramic bracket featuring an archwire slot and tiewings; self-ligating versions include a metal clip to secure the archwire without supplemental ligatures. Used in clinical orthodontic settings, the brackets allow clinicians to apply mechanical force to align teeth. The device is intended for use by dental professionals who select appropriate bonding cements, ligatures, and wires. By providing a stable attachment point for orthodontic hardware, the brackets enable controlled tooth movement, potentially improving dental alignment for the patient.

Clinical Evidence

Bench testing only. Performance validated through friction tests, flexural strength measurements, translucency, and shear bond tests. No clinical data provided.

Technological Characteristics

Polycrystalline alumina ceramic bracket; includes archwire slot and tiewings. Self-ligating models feature a metal clip. Mechanical device; no energy source or software. Dimensions/form factor not specified.

Indications for Use

Indicated for orthodontic movement of natural teeth in patients, 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

• In-Ovation C ceramic brackets (K060837)
• Mystique MB ceramic brackets (K082974)

Submission Summary (Full Text)

{0}------------------------------------------------

K123094

# 510(k) Summary

per 21CFR807.92

### CONTACT:

DEC 1 3 2012

Mr. Jinichi Watanabe Manager, Legal Sec. TOMY, Inc. Tenko Bldg. 3-16-7 Midoricho, Fuchu City, Tokyo 183-0006 Japan

DATE PREPARED: November 1, 2012

# TRADE OR PROPRIETARY NAME: ORTHODONTIC CERAMIC BRACKETS

CLASSIFICATION NAME: Bracket, Ceramic, Orthodontic, 872.5470

### PREDICATE DEVICES:

In-Ovation C ceramic brackets (K060837) Mystique MB ceramic brackets (K082974)

DEVICE DESCRIPTION: The ORTHODONTIC CERAMIC BRACKETS are designed to move teeth to improve their alignment.

The ORTHODONTIC CERAMIC BRACKETS are bonded to natural teeth by dental professionals to connect with orthodontic wires to cause tooth movement to a more preferred position.

No accessories are marketed with the ORTHODONTIC CERAMIC BRACKETS. The dental clinician is free to choose the bonding cement, supplemental ligatures and orthodontic wires for use with the brackets.

INTENDED USES: The ORTHODONTIC CERAMIC BRACKETS are indicated for orthodontic movement of natural teeth, excluding mandibular bicuspid teeth.

TECHNOLOGICAL CHARACTERISTICS: The ORTHODONTIC CERAMIC BRACKETS are composed of a polycrystalline alumina ceramic bracket, which includes an archwire slot and tiewings. The self-ligating ORTHODONTIC CERAMIC BRACKETS have a metal clip so that no other ligation of the archwire is needed.

Bench testing was performed to ensure that the ORTHODONTIC CERAMIC BRACKETS' performance was achieved and validated, which consisted of friction tests, flexural strength measurements, translucency, and shear bond tests.

{1}------------------------------------------------

The ORTHODONTIC CERAMIC BRACKETS were not evaluated for biocompatibility The ORTHODON He oblighten proven to be safe. All of the components have been because aramma has long over cate orthodontic ceramic brackets. No new questions of safety and effectiveness are raised with these devices.

SUBSTANTIAL EQUIVALENCE: No differences exist between these ORTHODONTIC SUBSTANTINE DQ OTTING DQ THIC Dredicate devices currently marketed in intended use, composition, design, function, physical properties, or performance. We believe that composition, design, function, physical propostrate these ORTHODONTIC CERAMIC the performance and provided tially equivalent in safety and effectiveness to the predicate device.

{2}------------------------------------------------

Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an eagle or other bird-like figure. The symbol is black and has a flowing, abstract design.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

December 13, 2012

TOMY, Incorporated C/O Carolyn M. Primus, PhD Consultant Primus Consulting 7046 Owl's Nest Terrace BRADENTON FL 34203

Re: K123094 -

Trade/Device Name: Orthodontic Ceramic Brackets Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: II Product Code: NJM Dated: September 28, 2012 Received: October 25, 2012

### Dear Dr. Primus:

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.

{3}------------------------------------------------

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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Kwame O. Ulmer

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices

Office of Device Evaluation

Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

## Indications for Use

510(k) Number (if known): K12 3 C 94

Device Name: ORTHODONTIC CERAMIC BRACKETS

Indications For Use: Orthodontic Ceramic Brackets are indicated for orthodontic movement of natural teeth, excluding mandibular bicuspid teeth.

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) 2012.12.13 Page 1 of 1 Susan Runner DDS, MA -07:01:32 -05'00'

(Division Sign-Off) rhot Notification Tomy, Inc. ORTHODONTIC CERAMIC BRACKETS Division of Anesthesiology, General Hosp Infection Control, Dental Devices

Page 16 of 75

K123094 510(k) Number:_