(161 days)
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
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.
The applicant, BIO CETEC CO., LTD., submitted a 510(k) premarket notification for their device, S-Line™ Orthodontic Ceramic Bracket, claiming substantial equivalence to the C-Line™ Orthodontic Ceramic Bracket (K163467) as the primary predicate device and DAMON 4Clear (K081415) as a reference device. Transbond™ XT (K073697) was also used as a bonding agent for performance testing.
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state formal "acceptance criteria" with numerical thresholds for performance. Instead, it describes performance tests conducted to demonstrate substantial equivalence by comparing the S-Line™ device to the reference device (DAMON 4Clear) and the primary predicate device (C-Line™). The reported "performance" is that the S-Line™ device's test results demonstrate substantial equivalence.
| Performance Test | Objective | Comparison Against | Reported Performance of S-Line™ |
|---|---|---|---|
| Wire Slot Torque test | Demonstrate stability to withstand torque force from wire. | Reference device (DAMON 4Clear) (implicit from context) | Substantially equivalent |
| Shear Bonding test | Demonstrate bond strength of brackets. | Reference device (DAMON 4Clear) (implicit from context) | Substantially equivalent |
| Bracket Removal Test | Demonstrate stability of brackets' de-bonding performance from the enamel surface with a plier. | Reference device (DAMON 4Clear) (implicit from context) | Substantially equivalent |
| Wire Drag Test | Measure friction between wire and bracket slot. | Reference device (DAMON 4Clear) (implicit from context) | Substantially equivalent |
| Door Pull-Out Test | Measure tensile force at the moment of fracture from the orthodontic wire. | Reference device (DAMON 4Clear) (implicit from context) | Substantially equivalent |
| Adhesive Strength Bonding Test | Study bonding of an adhesive to tooth structure or a bracket. | Not explicitly stated what it was compared against, likely also reference device. | Substantially equivalent |
| Biocompatibility Tests | ISO 10993-1, 10993-5, 10993-10 standards | ||
| Cytotoxicity | Assess for toxic effects on cells. | ISO 10993-5 | Non-cytotoxic |
| Mucosal Irritation | Assess for irritation to mucosal membranes. | ISO 10993-10 | None Irritation |
| Skin Sensitization | Assess for hypersensitivity reactions. | ISO 10993-10 | Do not show any hypersensitivity |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes used for the non-clinical performance tests. It also does not specify the data provenance (e.g., country of origin, retrospective/prospective). The tests were conducted internally by the manufacturer or a contracted lab to meet ISO standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not applicable as the study is a non-clinical performance study of a device (orthodontic bracket) and does not involve human subjects or expert assessment for ground truth in the context of clinical outcomes or imaging interpretation. Ground truth for these tests would be derived from the physical properties and measurements according to ISO standards.
4. Adjudication Method for the Test Set:
This information is not applicable for non-clinical performance testing. Adjudication methods are typically employed in clinical studies involving human readers/investigators.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
An MRMC comparative effectiveness study was not done. The study described is a non-clinical performance study of a medical device, not a study evaluating human reader performance with or without AI assistance.
6. Standalone Performance:
Standalone performance was done in the context of the device's physical and mechanical properties. The non-clinical performance tests (wire slot torque, shear bond, bracket removal, wire drag, door pull-out, adhesive strength, and biocompatibility) evaluate the device itself without human-in-the-loop interaction.
7. Type of Ground Truth Used:
The ground truth for the non-clinical performance tests was based on physical and mechanical measurements according to specified ISO standards. For example, bond strength would be a measured force, and biocompatibility would be assessed against the criteria of ISO 10993.
8. Sample Size for the Training Set:
This information is not applicable. The S-Line™ Orthodontic Ceramic Bracket is a physical medical device, not an AI/machine learning algorithm, and therefore does not have a "training set."
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the same reason as above.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
| 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 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: +82-2-704-2876 Fax: +82-2-704-2877
2. Submission Contact Person
MTech Group. 8310 Buffalo Speedway, Houston, TX 77025 Mr. Dave Kim, MBA Phone: 713-467-2607 Fax: 713-583-8988 Email: davekim@mtech-inc.net
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 | SubstantialEquivalenceAnalysis | |
|---|---|---|---|
| 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 ceramicbracket is intended to bebonded to a tooth to applypressure to a tooth from aflexible orthodontic wire toalter its position | C-Line™ orthodonticceramic bracket is intended tobe bonded to a tooth to applypressure to a tooth from aflexible orthodontic wire toalter its position. | SubstantialEquivalence |
| Material compositionof Bracket | PolycrystallineAlumina(100%) | PolycrystallineAlumina(100%) | SubstantialEquivalence |
| Material compositionof Door | PolycrystallineAlumina(100%) | N/A | Different-- |
| Material compositionof snap ring & pin | 300 Series Stainless Steel | N/A | Different- |
| Material compositionof colorants forbracket placementorientation | Polyvinylpyrrolidone(25wt%)Sweet whey powder(25wt%)TiO2(25wt%)Food dye(25wt%) | Polyvinylpyrrolidone(25wt%)Sweet whey powder(25wt%)TiO2(25wt%)Food dye(25wt%) | SubstantialEquivalence |
| Transparency | Half-transparency | Half-transparency | SubstantialEquivalence |
| Bracket design | MBT, ROTH designs with andwithout hook, conforming toISO 27020:2010 Dentistry –Brackets and tube for Use inOrthodontics | MBT, ROTH designs withand without hook,conforming to ISO27020:2010 Dentistry –Brackets and tube for Use inOrthodontics | SubstantialEquivalence |
| Self-ligatingmechanism | Yes | N/A | Different- |
| Design parts | Hook, Slot, Round home, baseDoor and marking | Hook, Slot, Round home,base and marking | SubstantialEquivalence |
| Bracket In-out(mm) | 0.65 to 1.08 | 0.56 to 1.45 | SubstantialEquivalence |
| Bracket Torque(°) | -22 to +17 | -22 to +17 | SubstantialEquivalence |
| BracketAngulation(°) | 0 to 11 | 0 to 11 | SubstantialEquivalence |
| Available slot sizes | 0.018 / 0.022 inch | 0.018 / 0.022 inch | SubstantialEquivalence |
| Orientation marking | Yes | Yes | SubstantialEquivalence |
| Sing use | Yes | Yes | SubstantialEquivalence |
| Non-SterilePackaging | Yes | Yes | SubstantialEquivalence |
| Target Population | Patients in need of teethalignment correction | Patients in need of teethalignment correction | SubstantialEquivalence |
| Anatomical Site | Teeth | Teeth | SubstantialEquivalence |
| Location of Use | Use only by professionalorthodontists | Use only by professionalorthodontists | SubstantialEquivalence |
| Bio-compatibility | All user directly contactingmaterials are compliance withISO10993 requirements | All user directly contactingmaterials are compliance withISO10993 requirements | SubstantialEquivalence |
| Candidate Device | Reference Device | SubstantialEquivalenceAnalysis | |
| 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 forUse | S-Line™ orthodontic ceramicbracket is intended to be bonded toa tooth to apply pressure to a toothfrom a flexible orthodontic wire toalter its position. | DAMON 4Clear is a ceramicbracket system intended to aid inthe movement of patient teethduring orthodontic treatment. | SubstantialEquivalence |
| Materialcomposition ofBracket | Polycrystalline Alumina | Polycrystalline Alumina | SubstantialEquivalence |
| Materialcomposition ofDoor | Polycrystalline Alumina | Polycrystalline Alumina | SubstantialEquivalence |
| Materialcomposition ofsnap ring & pin | 300 Series Stainless Steel | Different | |
| Materialcomposition ofcolorants forbracketplacementorientation | Polyvinylpyrrolidone(25wt%)Sweet whey powder(25wt%)TiO2(25wt%)Food dye(25wt%) | Different | |
| Transparency | Half-transparency | Half-transparency | SubstantialEquivalence |
| Bracket design | MBT, ROTH designs with andwithout hook, conforming to ISO27020:2010 Dentistry - Bracketsand tube for Use in Orthodontics | MBT, ROTH, High Torque designswith and without hook, conformingto ISO 27020:2010 Dentistry -Brackets and tube for Use inOrthodontics | SubstantialEquivalence |
| Self-ligatingmechanism | Yes | Yes | SubstantialEquivalence |
| Design parts | Hook, Slot, Round home, base andmarking | Hook, Slot, Round home, base andmarking | SubstantialEquivalence |
| Bracket In-out(mm) | 0.65 to 1.08 | 0.51 to 1.14 | Different |
| BracketTorque(°) | -22 to +17 | -11 to +22 | Different |
| BracketAngulation(°) | 0 to 11° | 2 to 9° | Different |
| Available slotsizes | 0.018 / 0.022 inch | 0.018 / 0.022 inch | SubstantialEquivalence |
| Orientationmarking | Yes | Yes | SubstantialEquivalence |
| Single use | Yes | Yes | SubstantialEquivalence |
| Non-SterilePackaging | Yes | Yes | SubstantialEquivalence |
| TargetPopulation | Patients in need of teeth alignmentcorrection | Patients in need of teeth alignmentcorrection | SubstantialEquivalence |
| Anatomical Site | Teeth | Teeth | SubstantialEquivalence |
| Location of Use | Use only by professionalorthodontists | Use only by professionalorthodontists | SubstantialEquivalence |
| Bio-compatibility | All user directly contactingmaterials are compliance withISO10993 requirements. | All user directly contactingmaterials are compliance withISO10993 requirements. | SubstantialEquivalence |
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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.
| HumanContactPart | Test Item | Test ReportNumber | Test Standard | Test Result |
|---|---|---|---|---|
| Mucosalmembrane | Cytotoxicity | ISO 10993-5 | Non-cytotoxic | |
| Mucosal Irritation | CR587171211 | ISO 10993-10 | None Irritation | |
| Skin Sensitization | ISO 10993-10 | Do not show anyhypersensitivity |
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.
§ 872.5470 Orthodontic plastic bracket.
(a)
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.(b)
Classification. Class II.