ORTHODONTIC CERAMIC BRACKETS 1.1

K160615 · Tomy, Inc. · NJM · Aug 26, 2016 · Dental

Device Facts

• Record ID: K160615
• Device Name: ORTHODONTIC CERAMIC BRACKETS 1.1
• Applicant: Tomy, Inc.
• Product Code: NJM · Dental
• Decision Date: Aug 26, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5470
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

ORTHODONTIC CERAMIC BRACKETS 1.1 are indicated for orthodontic movement of natural teeth.

Device Story

Orthodontic ceramic brackets bonded to natural teeth by dental professionals; used to connect with orthodontic wires to facilitate tooth movement. Device consists of polycrystalline alumina ceramic body with archwire slot, tiewings, and optional metal clip for self-ligating functionality. Designed to improve tooth alignment. Clinician uses device to exert pressure on teeth via archwires. Benefits include correction of tooth position.

Clinical Evidence

Bench testing only. No clinical or animal studies performed. Performance verified through shear bond strength and torque strength testing in accordance with ISO 27020.

Technological Characteristics

Polycrystalline (translucent) alumina ceramic. Mechanical lock base. Archwire slot, tiewings, and optional metal clip for self-ligation. Non-sterile, single-use. Conforms to ISO 27020.

Indications for Use

Indicated for orthodontic movement of natural teeth in patients requiring orthodontic treatment.

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

• Clarity Advanced Ceramic Brackets (K102803)
• Orthodontic Ceramic Brackets (K123094)

Submission Summary (Full Text)

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.

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

August 26, 2016

Tomy, Inc. c/o Ms. Carolyn Primus Consultant Primus Consulting 7046 Owls Nest Terr Bradenton, Florida 34203

Re: K160615

Trade/Device Name: Orthodontic Ceramic Brackets 1.1 Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NJM Dated: July 24, 2016 Received: July 28, 2016

Dear Ms. Carolyn 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.

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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

the quality systems (OS) 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 Industry and Consumer Education at its toll-free 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" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Michael J. Ryan -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

| DEPARTMENT OF HEALTH AND HUMAN SERVICES<br>Food and Drug Administration | Form Approved: OMB No. 0910-0120 |
|-------------------------------------------------------------------------|---------------------------------------------------------------|
| | Expiration Date: January 31, 2017<br>See PRA Statement below. |

| 510(k) Number ( <i>if known</i> ) | K16 0615 |
|-----------------------------------|-------------------------------------------------------------------------------------------|
| Device Name | ORTHODONTIC CERAMIC BRACKETS 1.1 |
| Indications for Use (Describe) | ORTHODONTIC CERAMIC BRACKETS 1.1 are indicated for orthodontic movement of natural teeth. |

Type of Use (Select one or both, as applicable)

| <div> <span style="text-decoration: underline;"></span> <label><input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> </div> | <div> <span style="text-decoration: underline;"></span> <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> </div> |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services

Food and Drug Administration

Office of Chief Information Officer

Paperwork Reduction Act (PRA) Staff

[e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."

FORM FDA 3881 (8/14) Page 1 of 1 PSC Publishing Services [phone] EF

Premarket Notification

Tomy Inc. ORTHODONTIC CERAMIC BRACKETS 1.1

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

# 510(k) Summary per 21CFR807.92

#### I. SUBMITTER

TOMY. Inc. Tenko Bldg. 3-16-7 Midoricho, Fuchu City, Tokyo 183-0006 Japan

PHONE: [phone] FAX #: [phone]

Contact Person: Mr. Jinichi Watanabe Date Prepared: August 24, 2016

## II. DEVICE

Name of Device: ORTHODONTIC CERAMIC BRACKETS 1.1 Common or Usual Name: Bracket, Ceramic, Orthodontic Classification Name: Orthodontic plastic bracket (21 CFR 872.5470) Regulatory Class: II Product Code: NJM

#### III. PREDICATE DEVICES

ORTHODONTIC CERAMIC BRACKETS are substantially equivalent to the following predicate devices with respect to intended use, materials, and design:

| 510(k) # | Device | Manufacturer |
|------------------------|-----------------------------------|-----------------|
| K102803<br>(primary) | Clarity Advanced Ceramic Brackets | 3M Unitek Corp. |
| K123094<br>(secondary) | Orthodontic Ceramic Brackets | TOMY, Inc. |

ORTHODONTIC CERAMIC BRACKETS 1.1 are equivalent to Clarity Advanced Ceramic Brackets (K102803) with regard to indications for use, materials, technological characteristics, and device design. ORTHODONTIC CERAMIC BRACKETS 1.1 have been slightly modified from TOMY Orthodontic Ceramic Brackets (K123094) to allow for the inclusion of the use of brackets for the mandibular bicuspid.

Premarket Notification

Page 25 of 160

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

## IV. DEVICE DESCRIPTION:

ORTHODONTIC CERAMIC BRACKETS 1.1 are designed to move teeth to improve their alignment.

ORTHODONTIC CERAMIC BRACKETS 1.1 are bonded to natural teeth by dental professionals to connect with orthodontic wires to cause tooth movement to a more preferred position.

#### V. INDICATIONS FOR USE:

ORTHODONTIC CERAMIC BRACKETS 1.1 are indicated for orthodontic movement of natural teeth.

#### VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES

ORTHODONTIC CERAMIC BRACKETS 1.1 are composed of a polycrystalline alumina ceramic, and have an orthodontic bracket design, which includes an archwire slot and tiewings. The self-ligating ORTHODONTIC CERAMIC BRACKETS 1.1 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 1.1 performance was achieved and verified.

The ORTHODONTIC CERAMIC BRACKETS 1.1 were not evaluated for biocompatibility because the materials are the same as the legally marketed predicates. TOMY made no material changes or manufacturing process changes since the clearance of their already marketed Orthodontic Ceramic Brackets (K123094). Therefore, no new questions of substantial equivalence are raised with the subject devices.

We believe the ORTHODONTIC CERAMIC BRACKETS 1.1 are substantially equivalent to the predicate devices identified above. The difference between the ORTHODONTIC CERAMIC BRACKETS 1.1 and the Orthodontic Ceramic Brackets (K123094) that TOMY currently markets is the INCLUSION of the brackets for the mandibular bicuspid. Additionally, the ORTHODONTIC CERAMIC BRACKETS 1.1 have the same intended use, composition, design, function, physical properties, and performance of the predicate device, 3M Unitek Corp.'s Clarity Advanced Ceramic Brackets (K102803). However, the difference being that the ORTHODONTIC CERAMIC BRACKETS 1.1 includes both self-ligating and non-self-ligating, whereas Clarity Advanced are non-self-ligating. However, self-ligating brackets would not be expected to impact the intended use

{5}------------------------------------------------

or performance of the brackets on the mandibular bicuspids.

We believe that the performance data provided herein support the substantial equivalence of the ORTHODONTIC CERAMIC BRACKETS 1.1.

Table VI-1 below provides a comparison of the subject devices and the predicate devices.

{6}------------------------------------------------

| | Subject Device<br>ORTHODONTIC CERAMIC<br>BRACKETS 1.1 | Primary Predicate Device<br>Clarity Advanced Ceramic<br>Brackets | Secondary Predicate Device<br>Orthodontic Ceramic Brackets | | |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | N/A | K102803 | K123094 | | |
| Manufacture | TOMY Inc. | 3M Unitek Corp. | TOMY Inc. | | |
| Device Name | Bracket, Ceramic, Orthodontic | Bracket, Ceramic, Orthodontic | Bracket, Ceramic, Orthodontic | | |
| Description | Orthodontic ceramic bracket | Orthodontic ceramic bracket | Orthodontic ceramic bracket | | |
| Medical Specialty | Dental | Dental | Dental | | |
| Product Code | NJM | NJM | NJM | | |
| Rag Number | 872.5470 | 872.5470 | 872.5470 | | |
| Class | 2 | 2 | 2 | | |
| Materials | Polycrystalline (translucent)<br>alumina | Polycrystalline (translucent)<br>alumina | Polycrystalline (translucent)<br>alumina | | |
| Base | Mechanical Lock Base | Glass-grit roughened Base | Mechanical Lock Base | | |
| Design | Archwire slot, tiewings for ligature<br>and identification marks for<br>placement<br>Hooks for ligation, for additional<br>tooth movement<br>Molded ceramic body with rounded<br>corners and edges<br>Slot to hold orthodontic wires | Archwire slot, tiewings for ligature<br>and identification marks for<br>placement<br>Hooks for ligation, for additional<br>tooth movement<br>Molded ceramic body with rounded<br>corners and edges<br>Slot to hold orthodontic wires | Archwire slot, tiewings for ligature<br>and identification marks for<br>placement<br>Hooks for ligation, for additional<br>tooth movement<br>Molded ceramic body with rounded<br>corners and edges<br>Slot to hold orthodontic wires | | |
| Ligation | Non-Self-Ligating | Non-Self-Ligating | Non-Self-Ligating | | |
| | Self-Ligating | | Self-Ligating | | |
| Indications for<br>Use | ORTHODONTIC CERAMIC<br>BRACKETS 1.1 are indicated for<br>orthodontic movement of natural<br>teeth. | Clarity Advanced Ceramic Brackets<br>are intended for use in orthodontic<br>treatment. The brackets are affixed<br>to teeth so that pressure can be<br>exerted on the teeth. | Orthodontic Ceramic Brackets are<br>indicated for orthodontic movement<br>of natural teeth, excluding<br>mandibular bicuspid teeth. | | |
| | Sterility | Non-Sterile | Non-Sterile | Non-Sterile | |
| | Utility | Single-use Only | Single-use Only | Single-use Only | |
| | | Subject Device<br>ORTHODONTIC CERAMIC<br>BRACKETS 1.1 | | Primary Predicate Device<br>Clarity Advanced Ceramic<br>Brackets | Secondary Predicate Device<br>Orthodontic Ceramic Brackets |
| | Picture of Device | Non-Self-Ligating<br>Mandibular<br>Bicuspid<br><br>Image: Non-Self-Ligating Mandibular Bicuspid Orthodontic Ceramic Bracket<br><br>Self-Ligating<br>Mandibular<br>Bicuspid<br><br>Image: Self-Ligating Mandibular Bicuspid Orthodontic Ceramic Bracket | Non-Self-Ligating for all<br>other Teeth<br><br>Image: Non-Self-Ligating Orthodontic Ceramic Bracket for all other teeth<br><br>Self-Ligating for<br>all other Teeth<br><br>Image: Self-Ligating Orthodontic Ceramic Bracket for all other teeth | Non-Self-Ligating<br><br>Image: Clarity Advanced Ceramic Bracket | Non-Self-Ligating<br><br>Image: Non-Self-Ligating Orthodontic Ceramic Bracket<br><br>Self-Ligating<br><br>Image: Self-Ligating Orthodontic Ceramic Bracket |

Table VI-1. Comparison of Subject ORTHODONTIC CERAMIC BRACKETS 1.1 to Predicates (3M Unitek Clarity Advanced Ceramic Brackets, K102803 and TOMY Orthodontic Ceramic Brackets, K123094)

Premarket Notification

Tomy Inc. ORTHODONTIC CERAMIC BRACKETS 1.1 Page 28 of 160

{7}------------------------------------------------

{8}------------------------------------------------

# VII. PERFORMANCE DATA

ORTHODONTIC CERAMIC BRACKETS 1.1 conform to the following Recognized Consensus Standard:

- . ISO 27020 First edition 2010-12-15 Dentistry - Brackets and Tubes for use in Orthodontics
ORTHODONTIC CERAMIC BRACKETS 1.1 were tested for Shear Bond Strength and Torque Strength.

All of the components found in the ORTHODONTIC CERAMIC BRACKETS 1.1 have been used in legally marketed devices. ORTHODONTIC CERAMIC BRACKETS 1.1 have the same composition as the predicate devices. Therefore, further biocompatibility testing is not necessary.

No animal studies or clinical testing have been required for these devices.

## VIII. CONCLUSIONS

There are no known substantial differences in terms of composition and mechanical properties between the ORTHODONTIC CERAMIC BRACKETS 1.1 and the predicate devices. This new 510(k) includes Orthodontic Ceramic Brackets (K123094) and their modified brackets. The difference in the modified brackets is the addition of the mandibular bicuspid brackets. Thus, the indication of use is equivalent to the predicate device Clarity ADVANCED Ceramic Brackets (K102803). The technological characteristics and materials are identical to Orthodontic Ceramic Brackets (K123094). Therefore, we believe that the information provided herein demonstrates that the ORTHODONTIC CERAMIC BRACKETS 1.1 are substantially equivalent to the predicate devices in design, principles of performance, and intended use.