(161 days)
No
The summary describes a physical orthodontic bracket and its mechanical and biocompatibility testing, with no mention of software, algorithms, or data processing related to AI/ML.
Yes.
The device description states it is used to "treat malocclusion" and "restore dental esthetics and functionality," which are therapeutic actions. It also applies "pressure to a tooth from a flexible orthodontic wire to alter its position," directly indicating a treatment function.
No
The device, an orthodontic bracket, is used to apply pressure to teeth to alter their position and treat malocclusion. It is a therapeutic device, not one that identifies or diagnoses a condition.
No
The device description and performance studies clearly indicate that this is a physical orthodontic bracket, not a software application. The tests performed are related to the mechanical properties and biocompatibility of a physical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The S-Line™ orthodontic ceramic bracket is a physical device bonded directly to a tooth. It works mechanically to apply pressure and alter tooth position. It does not analyze any biological specimens.
- Intended Use: The intended use is to correct malocclusion by applying pressure to teeth, not by analyzing biological samples.
- Performance Studies: The performance studies focus on the physical and mechanical properties of the bracket (bond strength, torque strength, friction, etc.) and its biocompatibility, not on the accuracy of diagnostic measurements from biological samples.
Therefore, the S-Line™ orthodontic ceramic bracket falls under the category of a medical device used for treatment, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
NJM
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Use only by professional orthodontists
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical performance tests were in accordance with:
- 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.
Biocompatibility Test Items:
- Cytotoxicity
- Mucosal Irritation
- Skin Sensitization
Test Results:
- Non-cytotoxic
- None Irritation
- Do not show any hypersensitivity
The biocompatibility test results demonstrated that there is no new concern in the cytotoxicity, sensitization, irritation, genotoxicity and no subchronic toxicity.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
1
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
2
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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3
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 |
4
| 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
Equivalence
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
bracket is intended to be
bonded to a tooth to apply
pressure to a tooth from a
flexible orthodontic wire to
alter its position | 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. | Substantial
Equivalence |
| Material composition
of Bracket | Polycrystalline
Alumina(100%) | Polycrystalline
Alumina(100%) | Substantial
Equivalence |
| Material composition
of Door | Polycrystalline
Alumina(100%) | N/A | Different-- |
| Material composition
of snap ring & pin | 300 Series Stainless Steel | N/A | Different- |
| Material composition
of colorants for
bracket placement
orientation | Polyvinylpyrrolidone(25wt%)
Sweet whey powder(25wt%)
TiO2(25wt%)
Food dye(25wt%) | Polyvinylpyrrolidone(25wt%)
Sweet whey powder(25wt%)
TiO2(25wt%)
Food dye(25wt%) | Substantial
Equivalence |
| Transparency | Half-transparency | Half-transparency | Substantial
Equivalence |
| Bracket design | MBT, ROTH designs with and
without hook, conforming to
ISO 27020:2010 Dentistry –
Brackets and tube for Use in
Orthodontics | MBT, ROTH designs with
and without hook,
conforming to ISO
27020:2010 Dentistry –
Brackets and tube for Use in
Orthodontics | Substantial
Equivalence |
| Self-ligating
mechanism | Yes | N/A | Different- |
| Design parts | Hook, Slot, Round home, base
Door and marking | Hook, Slot, Round home,
base and marking | Substantial
Equivalence |
| Bracket In-out(mm) | 0.65 to 1.08 | 0.56 to 1.45 | Substantial
Equivalence |
| Bracket Torque(°) | -22 to +17 | -22 to +17 | Substantial
Equivalence |
| Bracket
Angulation(°) | 0 to 11 | 0 to 11 | Substantial
Equivalence |
| Available slot sizes | 0.018 / 0.022 inch | 0.018 / 0.022 inch | Substantial
Equivalence |
| Orientation marking | Yes | Yes | Substantial
Equivalence |
| Sing use | Yes | Yes | Substantial
Equivalence |
| Non-Sterile
Packaging | Yes | Yes | Substantial
Equivalence |
| Target Population | Patients in need of teeth
alignment correction | Patients in need of teeth
alignment correction | Substantial
Equivalence |
| Anatomical Site | Teeth | Teeth | Substantial
Equivalence |
| Location of Use | Use only by professional
orthodontists | Use only by professional
orthodontists | Substantial
Equivalence |
| Bio-compatibility | All user directly contacting
materials are compliance with
ISO10993 requirements | All user directly contacting
materials are compliance with
ISO10993 requirements | Substantial
Equivalence |
| | Candidate Device | Reference Device | Substantial
Equivalence
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
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. | DAMON 4Clear is a ceramic
bracket system intended to aid in
the movement of patient teeth
during orthodontic treatment. | Substantial
Equivalence |
| Material
composition of
Bracket | Polycrystalline Alumina | Polycrystalline Alumina | Substantial
Equivalence |
| Material
composition of
Door | Polycrystalline Alumina | Polycrystalline Alumina | Substantial
Equivalence |
| Material
composition of
snap ring & pin | 300 Series Stainless Steel | | Different |
| Material
composition of
colorants for
bracket
placement
orientation | Polyvinylpyrrolidone(25wt%)
Sweet whey powder(25wt%)
TiO2(25wt%)
Food dye(25wt%) | | Different |
| Transparency | Half-transparency | Half-transparency | Substantial
Equivalence |
| Bracket design | MBT, ROTH designs with and
without hook, conforming to ISO
27020:2010 Dentistry - Brackets
and tube for Use in Orthodontics | MBT, ROTH, High Torque designs
with and without hook, conforming
to ISO 27020:2010 Dentistry -
Brackets and tube for Use in
Orthodontics | Substantial
Equivalence |
| Self-ligating
mechanism | Yes | Yes | Substantial
Equivalence |
| Design parts | Hook, Slot, Round home, base and
marking | Hook, Slot, Round home, base and
marking | Substantial
Equivalence |
| Bracket In-
out(mm) | 0.65 to 1.08 | 0.51 to 1.14 | Different |
| Bracket
Torque(°) | -22 to +17 | -11 to +22 | Different |
| Bracket
Angulation(°) | 0 to 11° | 2 to 9° | Different |
| Available slot
sizes | 0.018 / 0.022 inch | 0.018 / 0.022 inch | Substantial
Equivalence |
| Orientation
marking | Yes | Yes | Substantial
Equivalence |
| Single use | Yes | Yes | Substantial
Equivalence |
| Non-Sterile
Packaging | Yes | Yes | Substantial
Equivalence |
| Target
Population | Patients in need of teeth alignment
correction | Patients in need of teeth alignment
correction | Substantial
Equivalence |
| Anatomical Site | Teeth | Teeth | Substantial
Equivalence |
| Location of Use | Use only by professional
orthodontists | Use only by professional
orthodontists | Substantial
Equivalence |
| Bio-
compatibility | All user directly contacting
materials are compliance with
ISO10993 requirements. | All user directly contacting
materials are compliance with
ISO10993 requirements. | Substantial
Equivalence |
5
[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.
6
7
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:
8
- -. 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
Contact
Part | Test Item | Test Report
Number | Test Standard | Test Result |
|--------------------------|--------------------|-----------------------|---------------|-------------------------------------|
| Mucosal
membrane | Cytotoxicity | | ISO 10993-5 | Non-cytotoxic |
| | Mucosal Irritation | CR587171211 | ISO 10993-10 | None Irritation |
| | Skin Sensitization | | ISO 10993-10 | Do not show any
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.