ORTHODONTIC CERAMIC BRACKET

K102561 · Ht Co., Ltd. · NJM · Jan 25, 2011 · Dental

Device Facts

• Record ID: K102561
• Device Name: ORTHODONTIC CERAMIC BRACKET
• Applicant: Ht Co., Ltd.
• Product Code: NJM · Dental
• Decision Date: Jan 25, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5470
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

MISO Translucent Orthodontic Bracket is indicated for orthodontic movement of natural teeth, excluding mandibular bicuspid teeth.

Device Story

MISO Translucent Orthodontic Bracket is a single-crystal (mono clear sapphire) alumina orthodontic appliance. The device consists of an arch wire slot, four tie wings, and a base. It is adhered to a patient's tooth using adhesive. The arch wire slot holds an arch wire to apply force for tooth movement, while the tie wings secure an elastic o-ring to hold the arch wire in place. The translucent material provides improved aesthetics compared to metal or polycrystalline ceramic brackets. The device is used by orthodontists in a clinical setting to facilitate tooth alignment. It does not involve electronic components, software, or automated analysis.

Clinical Evidence

Bench testing only. Bond strength testing was performed according to ISO 11405:2003. The MISO bracket demonstrated a bond strength of 11.73 ± 3.04 MPa, compared to 5.51 ± 1.65 MPa for the Absolute bracket and 19.41 ± 5.08 MPa for the Pure bracket.

Technological Characteristics

Material: Single crystal (mono clear sapphire) alumina. Design: Three-part structure (arch wire slot, four tie wings, base). Available slot sizes: 0.018 / 0.022 inch. Available prescriptions: Roth, MBT, Edgewise. Testing standard: ISO 11405:2003 (adhesion to tooth structure). Biocompatibility: ISO 10993 compliant.

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

• Absolute bracket (K090567)
• Pure bracket (K073045)

Submission Summary (Full Text)

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

K102561

## 5. 510(k) Summary

## (per 21 CFR 807.92)

# JAN 2 5 2011

#### I. Applicant

Name : HT Co., Ltd. Address : HBI 513, Hanyang Univ., 1271, Sa3-dong, Ansan-si, Gyeonggi-do. 426-791. Korea

Contact Person: Jerry Choi Manager (Tel : [phone] Fax : [phone])

Date Prepared: Sep 6th , 2010

#### II. Device Name

- Proprietary Name: Common/ Usual Name: Classification Name: Regulation Number: Product Codes: Classification: Classification Panel:
MISO Translucent Orthodontic Bracket Orthodontic Plastic(Ceramic) Bracket Orthodontic appliance and accessories 21CFR872.5470 NJM II Dental

#### III. Predicate Device

MISO Translucent Orthodontic bracket is substantially equivalent to the Absolute bracket from Star Dentech Korea, Corp. and the Pure bracket from Ortho Technology. The Absolute bracket was most recently cleared.by the FDA on May 27, 2009 under 510(k) K090567. The Pure bracket was cleared by the FDA on December 18, 2007 under 510(k) K073045.

#### IV. Indications for use statement

MISO Translucent Orthodontic Bracket is indicated for orthodontic movement of natural teeth, excluding mandibular bicuspid teeth.

#### V. Description of the Device

MISO Translucent Orthodontic Bracket is comprised of single crystal(mono clear sapphire) alumina. The translucent properties of the bracket make the bracket less visible than polycrystalline ceramic and metal brackets. MISO Translucent Orthodontic Bracket consists of 3parts. The bracket consists of three distinct parts: (1) arch wire slot, (2) four tie wings, and (3) base. The arch wire slot allows the placenient of an arch wire which applies the necessary force to effect tooth movement. The tie wings allow the placement of an elastic o-ring, which holds the arch wire in place. The base is adhered to a patient's tooth using adhesive, thereby anchoring the bracket to the tooth.

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

#### VI. Summary of the Technical Characteristics

MISO Translucent Orthodontic Bracket was designed and tested using the following standard: .

- ISO 11405:2003 Dental materials -- Testing of adhesion to tooth . structure
#### VII. Conclusion of Safety & Effectiveness

.

There are no known substantial differences between the bracket defined in this 510(k) submission and the predicate devices. They have the same intended use and any differences in technological characteristics do not raise issues of safety and effectiveness.

| Company | Star Dentech | Ortho Technology<br>(OEM : Hubit) | HT Co., Ltd |
|-------------------------|-----------------------|-----------------------------------|-----------------------|
| Product Name | Absolute | Sapphire Ceramic Bracket | MISO |
| 510(k) Number | K090567 | K073045 | |
| Product Code(s) | NJM | NJM | NJM |
| Regulation # | 21CFR872.5470 | 21CFR872.5470 | 21CFR872.5470 |
| Class | II | II | II |
| Intended Use | Movement of teeth | Movement of teeth | Movement of teeth |
| Material | Alumina(mono crystal | Alumina(mono crystal | Alumina(mono crystal |
| Composition | ceramic bracket) | ceramic bracket) | ceramic bracket) |
| Translucent | Yes | Yes | Yes |
| Standards | ISO 10993 | ISO 10993 | ISO 10993 |
| Biocompatibility | Yes | Yes | Yes |
| Available Slot Sizes | 0.018 /0. 022 inch | 0.018 /0. 022 inch | 0.018 /0. 022 inch |
| Available | Roth / MBT / Edgewise | Roth / MBT / Edgewise | Roth / MBT / Edgewise |
| Prescriptions | | | |
| Bond Strength*<br>(MPa) | $5.51 \pm 1.65$ | $19.41 \pm 5.08$ | $11.73 \pm 3.04$ |

* Bond strength testing was carried out according to ISO 11405-2003(E). Results are detailed in Section 12.

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

Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes extending from its body, representing the department's commitment to health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle symbol.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Mr. Jerry Choi Manager HT Company, Limited HBI 513, Hanyang Univ., 1271, Sa3-dong Ansan-si, Gyeonggi-do 426-791, Korea

## JAN 2 5 301

Re: K102561

Trade/Device Name: MISO Translucent Orthodontic Bracket Regulation Number: 21 CFR 872.5470 Regulation Name: Orthondontic Appliance and Accessories Regulatory Class: II Product Code: NJM Dated: January 13, 2011 Received: January 13, 2011

Dear Mr. Choi:

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}------------------------------------------------

Page 2- Mr. Choi

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/ReportalProblem/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 vours.

hh for

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

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

# K102561

## 4. Indication for Use Statement

510(k) Number (if known): K102561

Device Name: MISO Translucent Orthodontic Bracket

Indications for Use:

MISO Translucent Orthodontic Bracket is indicated for orthodontic movement of natural teeth, excluding mandibular bicuspid teeth.

.

| Prescription Use | X (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)

(Division Sign-Off)

Division of Anesthesiology, General Hospital

Infection Control, Dental Devices

| 510(k) Number: | K102561 |
|----------------|---------|
|----------------|---------|

Page 1 of 1