(184 days)
No
The summary describes a physical orthodontic bracket and its performance testing, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is described as an orthodontic ceramic bracket which is used to apply pressure to a tooth from a flexible orthodontic wire to alter its position. This clearly indicates a therapeutic function, as it is treating a physical condition (misaligned teeth) by altering their position.
No
Explanation: The device description states its purpose is to "apply pressure to a tooth from a flexible orthodontic wire to alter its position," which is a treatment function, not a diagnostic one. It does not mention analyzing or interpreting any patient data to diagnose a condition.
No
The device description explicitly states it is a ceramic bracket intended to be bonded to a tooth, which is a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The C-Line™ orthodontic ceramic bracket is a physical device bonded to teeth to apply pressure and alter their position. It does not analyze biological samples or provide diagnostic information about a patient's health status.
- Intended Use: The intended use clearly states its purpose is to apply pressure to a tooth from a flexible orthodontic wire to alter its position, which is a mechanical function, not a diagnostic one.
- Device Description: The description focuses on the physical components and how it's used for tooth movement.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic results.
Therefore, the C-Line™ orthodontic ceramic bracket falls under the category of a medical device used for treatment (orthodontic correction), not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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
Product codes (comma separated list FDA assigned to the subject device)
NJM
Device Description
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.
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
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:
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical performance testing: wire slot drag test, wire slot torque test, shear test, and bracket removal test.
Key results:
- 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.
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
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of three human profiles facing right, layered on top of each other. The profiles are black and have a flowing, abstract design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the profiles.
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
1
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
2
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)
| Prescription Use (Part 21 CER 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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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- |
| gil(Hawolgok-dong 39-1), Seongbuk-gu, Seoul | |
| REPUBLIC OF KOREA | |
| Submitter's Telephone | +82 2-704-2876 |
| Official Correspondent | Dave Kim (davekim@mtech-inc.net) |
| Address | 8310 Buffalo Speedway, Houston, TX 77025 |
| Telephone | +713-467-2607 |
| Fax: | +713-583-8988 |
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 |
|---|---|
| ------------------------ | --------------- |
4
| 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
Equivalence
Analysis |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|
| 510(k) Number | Pending | K102803 | - |
| Device Name | C-Line™ | Clarity™ Advanced Ceramic
Brackets | - |
| Common Name | Orthodontic Ceramic bracket | Orthodontic Ceramic bracket | - |
| Manufacturer | BIO CETEC CORPORATION | 3M Unitek Corp. | - |
| Indication for Use | 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. | Clarity™ Advanced Ceramic
Brackets are intended for use
in orthodontic treatment. The
brackets are affixed to teeth
so that pressure can be
exerted on the teeth. | Substantial
Equivalence |
| Material composition
of Bracket | Polycrystalline
Alumina(100%) | Polycrystalline
Alumina(100%) | Substantial
Equivalence |
| Material composition
of colorants for | Polyvinylpyrrolidone(25wt%)
Sweet whey powder(25wt%) | | Different |
| bracket placement
orientation | TiO2(25wt%)
Food dye(25wt%) | | |
| 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 |
| Design parts | Hook, Slot, Round home, base
and marking | Hook, Slot, Round home,
base and marking | Substantial
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
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 |
5
6
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
7
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.