S-Line

K182193 · Biocetec Co., Ltd. · NJM · Jan 22, 2019 · Dental

Device Facts

• Record ID: K182193
• Device Name: S-Line
• Applicant: Biocetec Co., Ltd.
• Product Code: NJM · Dental
• Decision Date: Jan 22, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5470
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

S-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.

Device Story

S-Line™ is a self-ligating orthodontic ceramic bracket system. It consists of polycrystalline alumina brackets with a self-ligating door mechanism and stainless steel components. The device is bonded to the surface of teeth by a professional orthodontist using an adhesive. It functions by applying pressure to teeth via a flexible orthodontic wire to correct malocclusion and restore dental esthetics and functionality. The device is designed for single-use and is provided non-sterile. It features orientation markings to assist in placement. The system is used in a clinical setting by orthodontists to move teeth into desired positions, benefiting patients by correcting dental alignment.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing, including wire slot torque strength, shear bond strength, bracket removal testing, wire slot drag strength, door pull-out strength, and adhesive bonding testing. Biocompatibility testing was performed per ISO 10993-1, confirming the device is non-cytotoxic and does not cause mucosal irritation or skin sensitization.

Technological Characteristics

Materials: 100% Polycrystalline Alumina (bracket/door), 300 Series Stainless Steel (snap ring/pin). Design: Self-ligating, MBT/ROTH configurations. Standards: ISO 27020:2010 (brackets), ISO 11405:2015 (adhesion), ISO 29022:2013 (bond strength), ISO 10993 (biocompatibility). Dimensions: Slot sizes 0.018/0.022 inch; In-out 0.65-1.08mm; Torque -22° to +17°; Angulation 0° to 11°. Connectivity: None (mechanical). Sterilization: Non-sterile.

Indications for Use

Indicated for patients in need of teeth alignment correction to treat malocclusion.

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

• C-Line™ Orthodontic Ceramic Bracket (K163467)

Reference Devices

• DAMON 4Clear by Ormco Corporation (K081415)
• Transbond™ XT (K073697)

Submission Summary (Full Text)

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Image /page/0/Picture/10 description: The image contains 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.

Bio Cetec Co., Ltd. % Dave Kim, MBA President MTech Group 8310 Buffalo Speedway Houston, Texas 77025

Re: K182193

Trade/Device Name: S-Line™ Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NJM Dated: October 17, 2018 Received: October 26, 2018

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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

January 22, 2019

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Digitally signed by Mary S. Marv S. Runner -S3 Runner -S3 Date: 2019.01.22

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

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# Indications for Use

510(k) Number (if known) K182193

Device Name S-Line™

Indications for Use (Describe)

S-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

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

| <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) |
|----------------------------------------------------------------------------------|
| <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 510(k) Summary

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

Date: January 22, 2019

#### 1. 510K Applicant / Submitter:

BIO CETEC CO., LTD. RM 1001-1002 New T Castle, 108, Gasan digital 2-ro, Geumcheon-gu, Seoul, Republic of Korea Tel: [phone] Fax: [phone]

# 2. Submission Contact Person

MTech Group. 8310 Buffalo Speedway, Houston, TX 77025 Mr. Dave Kim, MBA Phone: [phone] Fax: [phone] Email: [e-mail]

# 3. Device

| Trade / Device Name: | S-Line TM |
|----------------------|-------------------------------|
| Classification Name: | Bracket, Ceramic, Orthodontic |
| Regulation Number: | 21CFR 872.5470 |
| Regulation Name: | Orthodontic Plastic Bracket |
| Regulatory Class: | II |
| Product Code: | NJM |

## 4. Predicate Device :

| Trade / Device Name: | C-Line™ Orthodontic Ceramic Bracket |
|----------------------|-------------------------------------|
| 510(k) Number | K163467 |
| Regulation Number: | 21 CFR 872.5470 |
| Regulation Name: | Orthodontic Plastic Bracket |
| Regulatory Class: | II |
| Product Code: | NJM |

#### 5. Reference Device 1:

| Trade / Device Name: | DAMON 4Clear by Ormco Corporation |
|----------------------|-----------------------------------|
| 510(k) Number: | K081415 |
| Regulation Number: | 21 CFR 872.5470 |
| Regulation Name: | Orthodontic Plastic Bracket |

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| Regulatory Class: | II |
|-------------------|-----|
| Product Code: | NJM |

#### Reference Device 2:

| Trade/proprietary Name | Transbond™ XT |
|------------------------|------------------------------------------------|
| 510(k) Number | K073697 |
| Regulation Name | Adhesive, bracket and tooth conditioner, resin |
| Regulation Number | 21 CFR 872.3750 |
| Regulatory Class: | Class II |
| Product Code | DYH |

## 6. Description:

S-Line™ orthodontic ceramic bracket is used to treat malocclusion, the abnormal occlusion of the upper and the lower teeth. It is intended to be applied on the surface of teeth to restore dental esthetics and functionality and it is designed to be used jointly with orthodontic wire.

## 7. Indications for Use

S-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.

## 8. Substantial Equivalence Discussion:

[S-Line™ vs. C-Line™(K163467)]

S-Line™ Orthodontic Ceramic bracket is substantially equivalent to C-Line™(K163467). C-Line™(K163467) is also manufactured by BIO CETEC Corporation. The differences of two products include ligating method & bracket structure. The following comparison table is presented to demonstrate substantial equivalence.

| | Subject Device | Predicate 1 | Substantial<br>Equivalence<br>Analysis |
|------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|
| 510(k) Number | K182193 | K163467 | - |
| Device Name | S-Line™ | C-Line™ | - |
| Common Name | Orthodontic Plastic bracket | Orthodontic Ceramic bracket | - |
| Manufacturer | BIO CETEC CORPORATION | BIO CETEC CORPORATION | - |
| Indication for Use | S-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 | C-Line™ orthodontic<br>ceramic bracket is intended to<br>be bonded to a tooth to apply<br>pressure to a tooth from a<br>flexible orthodontic wire to<br>alter its position. | Substantial<br>Equivalence |
| Material composition<br>of Bracket | Polycrystalline<br>Alumina(100%) | Polycrystalline<br>Alumina(100%) | Substantial<br>Equivalence |
| Material composition<br>of Door | Polycrystalline<br>Alumina(100%) | N/A | Different-- |
| Material composition<br>of snap ring & pin | 300 Series Stainless Steel | N/A | Different- |
| Material composition<br>of colorants for<br>bracket placement<br>orientation | Polyvinylpyrrolidone(25wt%)<br>Sweet whey powder(25wt%)<br>TiO2(25wt%)<br>Food dye(25wt%) | Polyvinylpyrrolidone(25wt%)<br>Sweet whey powder(25wt%)<br>TiO2(25wt%)<br>Food dye(25wt%) | Substantial<br>Equivalence |
| 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 designs with<br>and without hook,<br>conforming to ISO<br>27020:2010 Dentistry –<br>Brackets and tube for Use in<br>Orthodontics | Substantial<br>Equivalence |
| Self-ligating<br>mechanism | Yes | N/A | Different- |
| Design parts | Hook, Slot, Round home, base<br>Door and marking | Hook, Slot, Round home,<br>base and marking | Substantial<br>Equivalence |
| Bracket In-out(mm) | 0.65 to 1.08 | 0.56 to 1.45 | Substantial<br>Equivalence |
| Bracket Torque(°) | -22 to +17 | -22 to +17 | Substantial<br>Equivalence |
| 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 |
| | Candidate Device | Reference Device | Substantial<br>Equivalence<br>Analysis |
| 510(k) Number | K182193 | K081415 | - |
| Device Name | S-Line™ | DAMON 4Clear | - |
| Common Name | Orthodontic Ceramic bracket | Orthodontic Ceramic bracket | - |
| Manufacturer | BIOCETEC CO., LTD. | Ormco Corporation | - |
| Indication for<br>Use | S-Line™ orthodontic ceramic<br>bracket is intended to be bonded to<br>a tooth to apply pressure to a tooth<br>from a flexible orthodontic wire to<br>alter its position. | DAMON 4Clear is a ceramic<br>bracket system intended to aid in<br>the movement of patient teeth<br>during orthodontic treatment. | Substantial<br>Equivalence |
| Material<br>composition of<br>Bracket | Polycrystalline Alumina | Polycrystalline Alumina | Substantial<br>Equivalence |
| Material<br>composition of<br>Door | Polycrystalline Alumina | Polycrystalline Alumina | Substantial<br>Equivalence |
| Material<br>composition of<br>snap ring & pin | 300 Series Stainless Steel | | Different |
| Material<br>composition of<br>colorants for<br>bracket<br>placement<br>orientation | Polyvinylpyrrolidone(25wt%)<br>Sweet whey powder(25wt%)<br>TiO2(25wt%)<br>Food dye(25wt%) | | Different |
| Transparency | Half-transparency | Half-transparency | Substantial<br>Equivalence |
| Bracket design | MBT, ROTH designs with and<br>without hook, conforming to ISO<br>27020:2010 Dentistry - Brackets<br>and tube for Use in Orthodontics | MBT, ROTH, High Torque designs<br>with and without hook, conforming<br>to ISO 27020:2010 Dentistry -<br>Brackets and tube for Use in<br>Orthodontics | Substantial<br>Equivalence |
| Self-ligating<br>mechanism | Yes | Yes | Substantial<br>Equivalence |
| Design parts | Hook, Slot, Round home, base and<br>marking | Hook, Slot, Round home, base and<br>marking | Substantial<br>Equivalence |
| Bracket In-<br>out(mm) | 0.65 to 1.08 | 0.51 to 1.14 | Different |
| Bracket<br>Torque(°) | -22 to +17 | -11 to +22 | Different |
| Bracket<br>Angulation(°) | 0 to 11° | 2 to 9° | Different |
| Available slot<br>sizes | 0.018 / 0.022 inch | 0.018 / 0.022 inch | Substantial<br>Equivalence |
| Orientation<br>marking | Yes | Yes | Substantial<br>Equivalence |
| Single use | Yes | Yes | Substantial<br>Equivalence |
| Non-Sterile<br>Packaging | Yes | Yes | Substantial<br>Equivalence |
| Target<br>Population | Patients in need of teeth alignment<br>correction | Patients in need of teeth alignment<br>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-<br>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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[S-Line™ vs. DAMON 4Clear (K081415)]

S-Line™ Orthodontic Ceramic bracket is a self ligating type, same as DAMON 4Clear (K081415), the reference device. The following comparison table is presented to demonstrate substantial equivalence.

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S-Line™ Orthodontic Ceramic bracket does not have a new intended use. However, there are differences in some parameters (Material composition of door, Material composition of colorants for bracket placement orientation, Bracket Torque, Bracket Angulation) between S-Line 114 Orthodontic Ceramic bracket and DAMON 4Clear, the reference device.

Material compositions for door and snap ring pin of the subject device are Polycrystalline Alumina(100%) and 300 Series Stainless Steel, respectively. Materials used to S-Line™ are identical to C-Line™ (K163467), the primary predicate device.

Also the colorants for bracket placement orientation are the same as the primary predicate device, C-Line TM (K163467): Polyvinylpyrrolidone(25wt%). Sweet whey powder(25wt%), TiO2(25wt%), Food dye(25wt%).

S-Line ™ is a self ligating mechanism type which is the same as the reference device, DAMON 4Clear.

The bracket in-out, torque and angulation are identical to the primary predicate device whereas there are differences between S-Line™, the subject device and DAMON 4Clear, the reference device. The bracket in-out of the subject device is 0.65 to 1.08 mm whereas the range for the reference device is between 0.51 to 1.14 mm. The bracket torque for the subject device is -22 to +17° wider than the reference device's-11 to +22°. The bracket angulation for the subject device 2 to 11° whereas the reference device's range 2 to 9°.

The differences, however, do not impact the safety and effectiveness as demonstrated in the performance tests.

Transbond™ XT (K073697) is included as a reference device as it is the bonding agent used to demonstrate substantial equivalence in performance testing.

# 9. Performance Tests (Non-clinical)

Non-clinical performance tests were in accordance with:

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- -. ISO 27020:2010 Dentistry Brackets and tubes for use in Orthodontics
- -. ISO 11405:2015 Dentistry Testing of adhesion to tooth structure
- -. ISO 29022:2013 Dentistry Adhesive Notched edge sheer bond strength test.

The following tests for performance comparison between the subject and the reference device have been conducted; wire slot torque strength, shear bond strength, bracket removal test, wire slot drag strength, door pull-out strength and the adhesive strength bonding testing.

Wire Slot Torque test demonstrates stability to withstand the torque force from wire.

Shear Bonding test showed the bond strength of brackets.

The removal test with plier showed stability of brackets de-bonding performance from the enamel surface.

Wire Drag Test measured the friction between wire and bracket slot.

Door Pull-Out Test measured tensile force at the moment of the fracture from the orthodontic wire.

Also the adhesive strength bonding testing was conducted to study bonding of an adhesive to tooth structure or a bracket.

The result of the performance comparison test demonstrates that S-Line™ Orthodontic Ceramic bracket is substantially equivalent to the reference device.

Along with the above tests, biocompatibility testing accordance with ISO 10993-1 has been conducted for S-Line TM orthodontic ceramic bracket.

| Human<br>Contact<br>Part | Test Item | Test Report<br>Number | Test Standard | Test Result |
|--------------------------|--------------------|-----------------------|---------------|-------------------------------------|
| Mucosal<br>membrane | Cytotoxicity | | ISO 10993-5 | Non-cytotoxic |
| | Mucosal Irritation | CR587171211 | ISO 10993-10 | None Irritation |
| | Skin Sensitization | | ISO 10993-10 | Do not show any<br>hypersensitivity |

The biocompatibility test results demonstrated that there is no new concern in the cytotoxicity, sensitization, irritation, genotoxicity and no subchronic toxicity.

# 10. Conclusions:

Based on the information provided in this premarket notification, BIO CETEC CO., LTD. concludes that the S-Line™ Orthodontic Ceramic bracket is substantially equivalent to the primary predicate device and the reference device as described herein.