Ceramic Bracket

K180952 · Mem Dental Technology Co., Ltd. · NJM · Jun 7, 2019 · Dental

Device Facts

• Record ID: K180952
• Device Name: Ceramic Bracket
• Applicant: Mem Dental Technology Co., Ltd.
• Product Code: NJM · Dental
• Decision Date: Jun 7, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5470
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Ceramic Bracket is indicated for orthodontic movement of natural teeth.

Device Story

Ceramic brackets are orthodontic appliances bonded to natural teeth by dental professionals; they connect with orthodontic wires to exert pressure and move teeth to preferred positions. The device features a molded polycrystalline alumina ceramic body with an archwire slot, tie-wings for ligation, and hooks for additional tooth movement. It is used in a clinical dental setting. The device is non-self-ligating or self-ligating and is intended for single use. By providing a stable attachment point for orthodontic wires, the device facilitates controlled tooth movement, improving dental alignment for the patient.

Clinical Evidence

No clinical data or animal studies were required. Substantial equivalence is supported by bench testing, including biocompatibility (ISO 10993 series) and mechanical performance testing (ISO 27020, ISO 6872, ISO 29022, ISO 6474-2).

Technological Characteristics

Materials: Polycrystalline (translucent) alumina. Design: Molded ceramic body with archwire slot, tie-wings, and hooks. Mechanical lock base. Non-sterile. Single-use. Standards: ISO 27020, ISO 6872:2015, ISO 29022:2013, ISO 6474-2:2012.

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

• Orthodontic Ceramic Brackets 1.1 (K160615)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 7, 2019

MEM Dental Technology Co., Ltd Anita Chen Official Correspondent 2F., No.22, Ln.31, Sec.1, Huandong Rd., Xinshi Dist. Tainan City, 74146 Tw

Re: K180952

Trade/Device Name: Ceramic Bracket Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NJM Dated: April 20, 2019 Received: May 6, 2019

Dear Anita Chen:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Srinivas Nandkumar, Ph.D. Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K180952

Device Name Ceramic Bracket

Indications for Use (Describe)

Ceramic Bracket is indicated for orthodontic movement of natural teeth.

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

| | Prescription Use (Part 21 CFR 801 Subpart D) |
|--|----------------------------------------------|
| | Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 510(k) Summary

This 510(k) summary information is submitted as part of the Premarket Notification in compliance with requirements of CFR Part 807, Subpart E and Section 807.92

| | The assigned 510(k) Number: | K180952 |
|----|-----------------------------|--------------------------------------------|
| 1. | Submitter | |
| | Mailing Address | MEM Dental Technology Co., Ltd |
| | | 2F., No.22, Ln.31, Sec.1, Huandong Rd., |
| | | Xinshi Dist., Tainan City 74146, Taiwan |
| | | Phone: [phone] |
| | | Establishment Registration No.: 3009011037 |
| | Contact Person | Anita Chen |
| | Phone: | [phone] |
| | Fax: | [phone] |
| | E-mail: | [e-mail] |
| | Date Prepared | 2019.06.06 |

- Device Name 2

| Proprietary Name: | Ceramic Bracket |
|----------------------|----------------------------------------------------------|
| Common or Usual Name | Bracket, Ceramic, Orthodontic |
| Classification Name | Bracket Orthodontic Plastic Bracket (21 CFR<br>872.5470) |
| Product Code | NJM |
| Device | Ceramic Bracket |
| CFR Classification | CFR Part 872.5470 |
| Device Class | II |
| Classification Panel | Dental |
| Primary Predicate | |
| 510(k) number | K160615 |

3

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| Device name | Orthodontic Ceramic Brackets 1.1 |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | TOMY, INC<br>6 tenko blg. 3-16-7<br>midoricho, fuchu city, JP 183-0006 |
| 4 Device Description | Ceramic bracket are designed to move teeth to<br>improve their alignment. Ceramic bracket are bonded<br>to natural teeth by dental professionals to connect<br>with orthodontic wires to cause tooth movement to a<br>more preferred position.<br><br>Ceramic bracket are intended for use in affixed to a<br>tooth so that pressure can be exerted on the teeth. Use<br>bonding supplies to bond the bracket on to a tooth.<br>Use bonding supplies to bond the bracket on to a<br>tooth. Ceramic bracket are bonded to natural teeth<br>by dental professionals to connect with orthodontic<br>wires to cause tooth movement to a more preferred<br>position. |
| 5. Indication for Use: | Ceramic bracket is indicated for orthodontic<br>movement of natural teeth. |

| 6. Technological | A comparison of the device features, intended use, |
|----------------------------|----------------------------------------------------|
| Characteristics and | and other information demonstrates that the |
| Substantial Equivalence | Ceramic bracket is substantially equivalent to the |
| Comparison with Predicate: | predicate device as summarized in Table 1. |

Table 1

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| Manufacturer | MEM Dental Technology Co., Ltd. | Tomy, Inc. |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Subject Device | Primary Predicate Device |
| Device name | Ceramic bracket | Orthodontic Ceramic Brackets 1.1 |
| 510(k) Number | K180952 | K160615 |
| Indication for Use | Ceramic bracket is indicated for<br>orthodontic movement of<br>natural teeth. | Orthodontic Ceramic Brackets<br>1.1 are indicated for orthodontic<br>movement of natural teeth. |
| Classification name | Orthodontic Plastic Bracket | Orthodontic Plastic Bracket |
| Rag Number | 872.5470 | 872.5470 |
| Product Code | NJM | NJM |
| Class | II | II |
| Medical Specialty | Dental | Dental |
| Ligation | Non-Self-Ligating | Non-Self-Ligating |
| | Self-Ligating | Self-Ligating |
| Base | Mechanical Lock Base | Mechanical Lock Base |
| Sterility | Non-Sterile | Non-Sterile |
| Materials | Polycrystalline (translucent) alumina | Polycrystalline (translucent) alumina |
| Utility | Single-use only | Single-use only |
| Design | Archwire slot, tiewings for ligature and<br>identification marks for placement<br>Hooks for ligation, for additional tooth<br>movement<br>Molded ceramic body with rounded<br>corners and e Slot to hold orthodontic<br>wires edges | Archwire slot, tiewings for ligature and<br>identification marks for placement<br>Hooks for ligation, for additional tooth<br>movement<br>Molded ceramic body with rounded<br>corners and e Slot to hold orthodontic<br>wires edges |

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| Manufacturer | MEM Dental Technology Co., Ltd. | Tomy, Inc. |
|-------------------|--------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Subject Device | Primary Predicate Device |
| Device name | Ceramic bracket | Orthodontic Ceramic Brackets 1.1 |
| 510(k) Number | K180952 | K160615 |
| Picture of Device | Image: Non-Self-Ligating<br>Image: Self-Ligating | Image: Non-Self-Ligating Mandibular Bicuspid<br>Image: Non-Self-Ligating for all other Teeth<br>Image: Self-Ligating Mandibular Bicuspid<br>Image: Self-Ligating for all other Teeth |

## 7. Performance Testing

Performance testing has been carried out to demonstrate that this device meets the performance specifications for its intend use. The following tests were performed on the device:

· ISO 27020 First edition 2010-12-15 Dentistry - Brackets and Tubes for use in Orthodontics

Ceramic Bracket.

All of the components found in the Ceramic Bracket have been used in legally marketed devices, such as the primary predicate Orthodontic Ceramic Brackets 1.1.

Biocompatibility Testing

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The biocompatibility evaluation and testing of the Product name was conducted in accordance with the following standards and guidance, as recognized by the FDA:

- . FDA Draft Guidance - Use of International Standard ISO- 10993, "Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing", dated 04-23-2013
- . ISO 10993-3,Biological evaluation of medical device-Part 3: Test for genotoxicity, carcinogenicity and reproductive toxicity.
- . ISO 10993-5, Biological evaluation of medical device-Part 5: Tests for in vitro cytotoxicity.
- . ISO 10993-10. Biological evaluation of medical device-Part 10: Tests for irritation and skin sensitization.
- ISO 10993-11, Biological evaluation of medical device-Part 11: Tests for systemic toxicity.
- . ISO 10993-12, Biological evaluation of medical device-Part 12: Sample preparation and reference materials.

### Sterilization Status

The Ceramic Bracket are provided non-sterile and are not processed prior to use.

#### Mechanical testing

Ceramic bracket's mechanical function including Shear Bond Strength, Torque Strength test and structure integrity were tested. The results were compared to recognized standards (ISO 6872:2015, ISO 29022:2013, ISO 27020:2010, ISO 6474-2:2012) and clinical literature data to demonstrate substantial equivalence.

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

#### 8. Conclusion

Based on the intended use and/or indications for use, technological characteristics, performance testing and comparison to the predicate device, the Ceramic bracket is substantially equivalent.