C-Line Orthodontic Ceramic Bracket

K163467 · Biocetec Co., Ltd. · NJM · Jun 14, 2017 · Dental

Device Facts

• Record ID: K163467
• Device Name: C-Line Orthodontic Ceramic Bracket
• Applicant: Biocetec Co., Ltd.
• Product Code: NJM · Dental
• Decision Date: Jun 14, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5470
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

C-LineTM orthodontic ceramic bracket is intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position

Device Story

C-Line Orthodontic Ceramic Bracket is a passive orthodontic component bonded to teeth to facilitate tooth movement. Device consists of a translucent polycrystalline alumina body with a bonding base and color-coded markings for positioning. Used by professional orthodontists in clinical settings. Device receives mechanical input from flexible orthodontic wires inserted into the bracket slot; pressure exerted by wire on bracket transfers to tooth to alter position. Benefits include tooth alignment correction. Device is single-use and non-sterile.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing including wire slot drag, wire slot torque, shear bonding, and bracket removal tests. Biocompatibility testing performed per ISO 10993 standards (cytotoxicity, sensitization, irritation, systemic toxicity, and degradation products).

Technological Characteristics

Material: 100% polycrystalline alumina. Design: MBT/ROTH configurations with/without hooks. Dimensions: 0.018/0.022 inch slot sizes. Standards: ISO 27020:2010 (brackets/tubes), ISO 11405:2015 (adhesion), ISO 14971:2012 (risk management). Biocompatibility: ISO 10993 series. Single-use, non-sterile.

Indications for Use

Indicated for patients requiring teeth alignment correction via orthodontic treatment. Contraindications not specified.

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 Bracket (K102803)

Reference Devices

• Transbond XT (K073697)

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

June 14, 2017

Biocetec Co., Ltd % Dave Kim Medical Device Regulatory Affairs Mtech Group 8310 Buffalo Speedway Houston, Texas 77025

Re: K163467

Trade/Device Name: C-Line Orthodontic Ceramic Bracket Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NJM Dated: May 17, 2017 Received: May 22, 2017

Dear Dave Kim:

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

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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,

Mary S. Runner -A

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

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# Indications for Use

510(k) Number (if known)

### Device Name

C-LineTM Orthodontic Ceramic Bracket

### Indications for Use (Describe)

C-LineTM orthodontic ceramic bracket is intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position

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

| <div> <span> <svg class="bi bi-check-square-fill" fill="currentColor" height="1em" viewbox="0 0 16 16" width="1em" xmlns="http://www.w3.org/2000/svg"> <path d="M2 0a2 2 0 0 0-2 2v12a2 2 0 0 0 2 2h12a2 2 0 0 0 2-2V2a2 2 0 0 0-2-2H2zm10.03 4.97a.75.75 0 0 0-1.08.022L7.477 9.417 5.384 7.323a.75.75 0 0 0-1.06 1.06L6.97 11.03a.75.75 0 0 0 1.079-.02l3.992-4.99a.75.75 0 0 0-.01-.052z" fill-rule="evenodd"></path> </svg> </span>Prescription Use (Part 21 CER 801 Subpart D) </div> |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <svg class="bi bi-square" fill="currentColor" height="1em" viewbox="0 0 16 16" width="1em" xmlns="http://www.w3.org/2000/svg"> <path d="M14 1H2a1 1 0 0 0-1 1v12a1 1 0 0 0 1 1h12a1 1 0 0 0 1-1V2a1 1 0 0 0-1-1zM2 0a2 2 0 0 0-2 2v12a2 2 0 0 0 2 2h12a2 2 0 0 0 2-2V2a2 2 0 0 0-2-2H2z" fill-rule="evenodd"></path> </svg> </span>Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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# 510(k) Summary

This summary of 510(k) information is being submitted in accordance with requirements of 21 CFR Part 807.92.

#### Date 510k summary prepared: May 17, 2017

#### I. SUBMITTER

| Submitter's Name | BIOCETEC CO., LTD. |
|------------------------|------------------------------------------------------------------------------------------------------------------|
| Submitter's Address | RM 3-952AB, H1-dong, KIST, 5, Hwarang-ro 14-<br>gil(Hawolgok-dong 39-1), Seongbuk-gu, Seoul<br>REPUBLIC OF KOREA |
| Submitter's Telephone | [phone] |
| Official Correspondent | Dave Kim ([e-mail]) |
| Address | 8310 Buffalo Speedway, Houston, TX 77025 |
| Telephone | [phone] |
| Fax: | [phone] |

#### II. DEVICE

C-Line™ Orthodontic Ceramic Bracket Trade/proprietary Name Common or Usual Name Orthodontic Ceramic Bracket Regulation Name Bracket, Ceramic, Orthodontic Regulation Number 21 CFR 872.5470 Product Code NJM Regulatory Class Class II

#### III. PREDICATE DEVICE

| Primary Manufacturer | 3M UNITEK Corporation |
|----------------------|-------------------------------------|
| Device Name | Clarity Advanced Ceramic Bracket |
| 510(k) Number | K102803 |
| Regulation Name | Orthodontic Plastic Bracket |
| Regulation Number | 21 CFR 872.5470 (Product Code: NJM) |
| Regulatory Class | Class II |
| Over the Counter Use | |

#### IV. REFERENCE DEVICE

| Trade/proprietary Name | Transbond™ XT |
|------------------------|---------------|
|------------------------|---------------|

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| 510(k) Number | K073697 |
|-------------------|------------------------------------------------|
| Regulation Name | Adhesive, bracket and tooth conditioner, resin |
| Regulation Number | 21 CFR 872.3750 |
| Product Code | DYH |
| Regulatory Class | Class II |

#### DEVICE DESCRIPTION V.

C-Line ™ orthodontic ceramic brackets are intended to be bonded to a tooth to apply pressure to a tooth to alter its position. C-Line ™ orthodontic ceramic brackets consist of a translucent alumina body and a bonding base. The bracket's color marking and cords indicates the bracket positioning and facilitate bracket identification.

#### INDICATIONS FOR USE: VI.

C-Line™ orthodontic ceramic bracket is intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position.

#### PREDICATE COMPARISON VII.

| | Candidate Device | Predicate 1 | Substantial<br>Equivalence<br>Analysis |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|
| 510(k) Number | Pending | K102803 | - |
| Device Name | C-Line™ | Clarity™ Advanced Ceramic<br>Brackets | - |
| Common Name | Orthodontic Ceramic bracket | Orthodontic Ceramic bracket | - |
| Manufacturer | BIO CETEC CORPORATION | 3M Unitek Corp. | - |
| Indication for Use | C-Line™ orthodontic ceramic<br>bracket is intended to be<br>bonded to a tooth to apply<br>pressure to a tooth from a<br>flexible orthodontic wire to<br>alter its position. | Clarity™ Advanced Ceramic<br>Brackets are intended for use<br>in orthodontic treatment. The<br>brackets are affixed to teeth<br>so that pressure can be<br>exerted on the teeth. | Substantial<br>Equivalence |
| Material composition<br>of Bracket | Polycrystalline<br>Alumina(100%) | Polycrystalline<br>Alumina(100%) | Substantial<br>Equivalence |
| Material composition<br>of colorants for | Polyvinylpyrrolidone(25wt%)<br>Sweet whey powder(25wt%) | | Different |
| bracket placement<br>orientation | TiO2(25wt%)<br>Food dye(25wt%) | | |
| Transparency | Half-transparency | Half-transparency | Substantial<br>Equivalence |
| Bracket design | MBT, ROTH designs with and<br>without hook, conforming to<br>ISO 27020:2010 Dentistry –<br>Brackets and tube for Use in<br>Orthodontics | MBT, ROTH, High Torque<br>designs with and without<br>hook, conforming to ISO<br>27020:2010 Dentistry –<br>Brackets and tube for Use in<br>Orthodontics | Substantial<br>Equivalence |
| Design parts | Hook, Slot, Round home, base<br>and marking | Hook, Slot, Round home,<br>base and marking | Substantial<br>Equivalence |
| Bracket In-out(mm) | 0.56 to 1.45 | 0.51 to 1.14 | Different |
| Bracket Torque(°) | -22 to +17 | -17 to +17 | Different |
| Bracket<br>Angulation(°) | 0 to 11 | 0 to 11 | Substantial<br>Equivalence |
| Available slot sizes | 0.018 / 0.022 inch | 0.018 / 0.022 inch | Substantial<br>Equivalence |
| Orientation marking | Yes | Yes | Substantial<br>Equivalence |
| Sing use | Yes | Yes | Substantial<br>Equivalence |
| Non-Sterile<br>Packaging | Yes | Yes | Substantial<br>Equivalence |
| Target Population | Patients in need of teeth<br>alignment correction | Patients in need of teeth<br>alignment correction | Substantial<br>Equivalence |
| Anatomical Site | Teeth | Teeth | Substantial<br>Equivalence |
| Location of Use | Use only by professional<br>orthodontists | Use only by professional<br>orthodontists | Substantial<br>Equivalence |
| Bio-compatibility | All user directly contacting<br>materials are compliance with<br>ISO10993 requirements. | All user directly contacting<br>materials are compliance with<br>ISO10993 requirements. | Substantial<br>Equivalence |

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C-Line™ and the predicate device have identical indication for use statements and the same intended use.

The 510k(k) also includes data from bench testing to evaluate the performance of C-Line™ to the predicate device. The properties evaluated include wire slot drag test, wire slot torque test, shear test, and bracket removal test.

There are differences in the device design characteristics. The subject device's bracket in-out is 0.56 to 1.45 mm whereas the predicate device's range is between 0.51 to 1.14 mm. The bracket torque for the subject device is -22 to +17° wider than the predicate device's-17 to +17°. Also, the predicate device and subject device have a different color coding system to indicate the bracket positioning and identification.

These differences do not raise different questions of safety or effectiveness.

#### SUMMARY OF NON-CLINICAL TESTS VIII.

Non-clinical performance testing was conducted as follows: design characteristics based on and in accordance with ISO 27020:2010 Dentistry - Brackets and tubes for use in Orthodontics; adhesive strength and analysis of detached teeth surface were conducted in accordance with ISO 11405:2015. Dentistry -Testing of adhesion to tooth structure; in-house comparative performance testing was conducted for the submission device and the predicate device, including wire slot drag test, wire slot torque test, shear test, and bracket removal test. A risk analysis was conducted based on ISO 14971:2012 Medical Devices Application of risk management to medical devices:

According to the bench test result of the two ceramic brackets, their performances in the technical property seemed similar to one another. In the Wire Slot Torque test, C-Line brackets had higher torque strength than Clarity Advanced brackets due to the higher in/out thickness of C-Line.

In the Shear Bonding test, two brackets had a very similar shear strength. When two ceramic brackets were debonded, there were no fracture occurred.

The removal test with plier showed that the most of adhesive remained on the enamel despite of base patterns. C-Line brackets had a tendency to remain adhesive lower than Clarity Advanced because of undercut pattern base.

In the Wire Drag Test, the result of test data was similar for both brackets. Because two brackets were made of same raw materials(Alumina) and the structure of both product is poly-crystal alumina. Also, the width of the slot is approximatively the same as each other.

#### IX. BIOCOMPATIBILTY TESTING

Biocompatibility testing including cytotoxicity, sensitization, oral mucosal irritation was completed according to the following standards:

ISO 10993-1 (2010) Biological Evaluation of Medical Devices -Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

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ISO 10993-5 (2009) Biological Evaluation of Medical Devices - Part 5 Cytotoxicity ISO 10993-10 (2010) Biological Evaluation of Medical Devices Part 10: Tests for irritation and skin sensitization

ISO 10993-11 (2006) Biological Evaluation of Medical Devices Part 11: Tests for systemic toxicity test

ISO 10993-14 (2001) Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics

#### X. SUMMARY OF CLINICAL TESTS

Clinical testing was not required to demonstrate the substantial equivalence of the C-Line™ orthodontic ceramic bracket to its predicate device.

#### XI. CONCLUSIONS

Based on the information above, C-Line™ orthodontic ceramic bracket have similar indications for use and intended use. Both have shown similar performance results in these bench tests In conclusion, C-Line™ orthodontic ceramic bracket is substantially equivalent to the predicate device and would be comparable with Clarity Advanced ceramic bracket in functional performance during the course of orthodontic treatment.