(1 days)
A-Line Advanced 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.
This orthodontic bracket is made of polycrystalline ceramic and is used for the treatment of malocclusion. It is designed to be attached to the surface of patients' teeth and be connected to the orthodontic wire in order to apply physical pressure on the tooth movement. Each model differs in size and dimension, color identification as they are attached to the tooth surface corresponding to 20 of the 28 permanent teeth.
The provided text is a 510(k) summary for a medical device called "A-Line Advanced" (an orthodontic ceramic bracket). It does not describe a study involving an algorithm, AI, or human readers, so many of the requested items are not applicable.
Here's the information that can be extracted and a note for those that are not present:
1. A table of acceptance criteria and the reported device performance
The document provides the following performance characteristics and specifications, which serve as acceptance criteria for the device:
| Item | Reference Standards | Specification | Reported Performance (from testing) |
|---|---|---|---|
| Physical and Performance Characteristics | |||
| Dimension | ISO 27020(2019) | -. Torque(±3°)-. Angulation(±3°)-. Offset (±3°)-. Slot length(±0.1 mm)-. Slot width(±0.1 mm)-. Slot depth(±0.1 mm)-. In-out(±0.1 mm) | Stated as passed |
| Corrosion | ISO 22674(2016)ISO 10271(2020) | 1.642 ± 0.157 ug/cm² in 7 days | Stated as passed |
| Hazardous elements | ISO 22674(2016) | -. Be : 0.00 wt %-. Cd : 0.00 wt %-. Pb : 0.00 wt %-. Ni : 36.59 wt % | Stated as passed |
| Adhesion Test to tooth | ISO 11405(2015) | -. Mean±SD : 7.22 ± 2.34 MPa | Stated as passed |
| Biocompatibility Testing | |||
| Cytotoxicity | ISO 10993-5 | Non-cytotoxic | Non-cytotoxic |
| Mucosal Irritation | ISO 10993-23 | None Irritation | None Irritation |
| Skin Sensitization | ISO 10993-10 | Do not show any hypersensitivity | Do not show any hypersensitivity |
| Acute systemic toxicity | ISO 10993-11 | Do not show any acute systemic toxicity | Do not show any acute systemic toxicity |
| Comparative Performance (Bench Tests) | |||
| Wire Slot Torque strength | ISO 27020 | (Implicitly compared to predicate device) | Result demonstrates stability |
| Shear Bond Strength | ISO 11405 | (Implicitly compared to predicate device) | Showed bond strength |
| Bracket Removal Test | N/A | (Implicitly compared to predicate device) | Showed stability of de-bonding performance |
| Wire Slot Drag Strength | N/A | (Implicitly compared to predicate device) | Measured friction |
| Door Pull-Out Strength | N/A | (Implicitly compared to predicate device) | Measured tensile force at fracture |
| Adhesive Strength Bonding | ISO/TS 11405 | (Implicitly compared to predicate device) | Conducted to study bonding |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes for each test mentioned (e.g., how many brackets were tested for corrosion, how many teeth for adhesion, etc.). The provenance of the data is from non-clinical laboratory testing performed by "KTR (Korea Testing & Research Institute)" and "Seoul National University Dental Hospital Dental Material & Device Evaluation Center." These are non-clinical (bench) tests, not human data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a non-clinical device that does not involve expert image interpretation or ground truth establishment in the context of the requested AI/human reader study format. A "biological evaluation written by an expert [Seoul National University Dental Hospital Dental Material & Device Evaluation Center]" was used to justify not conducting certain biocompatibility tests. No specific number or individual qualifications are listed beyond "expert."
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. There is no human reading or adjudication process described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a physical medical device (orthodontic bracket), not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device would be defined by established engineering and biocompatibility standards (e.g., ISO standards) and the physical properties and performance characteristics of the device when subjected to these standardized tests. It does not involve expert consensus on medical images or pathology.
8. The sample size for the training set
Not applicable. This is a physical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This is a physical device, not an AI model.
{0}------------------------------------------------
Image /page/0/Picture/0 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.
June 6, 2023
Biocetec Co., Ltd % Dave Yungvirt CEO Third Party Review Group, LLC 25 Independence Blvd Warren, New Jersey 07059
Re: K231635
Trade/Device Name: A-Line Advanced Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic plastic bracket Regulatory Class: Class II Product Code: NJM Dated: May 29, 2023 Received: June 5, 2023
Dear Dave Yungvirt:
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.
{1}------------------------------------------------
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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Michael E. Adjodha -S
Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic. Anesthesia. Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K231635
Device Name A-Line Advanced
Indications for Use (Describe)
A-Line Advanced orthodontic ceramic bracket is intended to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
510(k) Summary
The following 510(k) summary is being submitted as required by 21 CFR Part 807.92;
| 1.1 | Submitter: | BIOCETEC CO., LTD.RM 1001-1002 New T Castle, 108, Gasan digital 2-ro,Geumcheon-gu, Seoul,REPUBLIC OF KOREATel: +82-2-704-2876Fax: +82-2-704-2877 |
|---|---|---|
| Contact Person:(Official Correspondent) | Hee Sue JinRM 1001-1002 New T Castle, 108, Gasan digital 2-roGeumcheon-gu, Seoul, REPUBLIC OF KOREATel: +82-2-704-2876Email: hsjin@biocetec.com | |
| Date Prepared: | 23 May, 2023 |
1.2 Device Identification
| Device Trade Name | A-Line Advanced |
|---|---|
| Common Name | Orthodontic Ceramic bracket |
| Classification Name, Number | Bracket, Ceramic, Orthodontic (21 CFR 872.5470) |
| Device Classification | II |
| Product Code | NJM |
- 1.3 Predicated or legally marketed devices which are substantially equivalent Predicated device: K182193, "S-Line", manufactured by "BIOCETEC CO., LTD."
1.4 Device Description
This orthodontic bracket is made of polycrystalline ceramic and is used for the treatment of malocclusion. It is designed to be attached to the surface of patients' teeth and be connected to the orthodontic wire in order to apply physical pressure on the tooth movement. Each model differs in size and dimension, color identification as they are attached to the tooth surface corresponding to 20 of the 28 permanent teeth.
[Principle of operation]
The orthodontic bracket is a device that evenly arranges the teeth of malocclusion and, as a device, moves the teeth to the position of the prescription applied to the bracket through an orthodontic wire.
[Bracket Type]
| Standard Type | Slot Type | Slot size(inch) |
|---|---|---|
| MBT | MBT022 | 0.022 X 0.028 |
| Roth | Roth018 | 0.018 X 0.025 |
{4}------------------------------------------------
| Roth022 | 0.022 X 0.028 | |
|---|---|---|
| [Physical and Performance Characteristics] | ||
| Item | Reference Standards | Specification |
| Dimension | ISO 27020(2019) | -. Torque(±3°)-. Angulation(±3°)-. Offset (±3°)-. Slot length(±0.1 mm) -.Slot width(±0.1 mm) -.Slot depth(±0.1 mm) -. In-out(±0.1 mm) |
| Corrosion | ISO 22674(2016)ISO 10271(2020) | 1.642 ± 0.157 ug/cm² in 7 days |
| Hazardous elements | ISO 22674(2016) | -. Be : 0.00 wt %-. Cd : 0.00 wt %-. Pb : 0.00 wt %-. Ni : 36.59 wt % |
| Adhesion Test to tooth | ISO 11405(2015) | -. Mean±SD : 7.22 ± 2.34 MPa |
1.5 Statement of Indication for use
A-Line Advanced 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.
1.6 Non-clinical Test Conclusion
Non-clinical performance tests were performed as followings:
[Biocompatibility Testing]
• ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
· ISO 10993-3 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
-
ISO 10993-5 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity
• ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization -
ISO 10993-11 Biological evaluation of medical devices Part 11: Tests for systemic toxicity
-
ISO 10993-23 Biological evaluation of medical devices Part 23: Tests for irritation
-
ISO 10993-14 Identification and quantification of degradation products from ceramics
-
ISO 10993-15 Identification and quantification of degradation products from metals and alloys
Biocompatibility testing in accordance with ISO 10993-1 has been conducted for A-Line Advanced orthodontic ceramic bracket.
(1) Conducted Biocompatibility Testing Results
Cytotoxicity, Mucosal Irritation, Skin Sensitization, Acute systemic toxicity
| HumanContactPart | Test Item | Test ReportNumber | Test Standard | Test Result | Laboratory |
|---|---|---|---|---|---|
| Mucosal | Cytotoxicity | MGK-2022- | ISO 10993-5 | Non-cytotoxic | KTR(Korea) |
Actually, A-Line Advanced has done the tests as follows:
{5}------------------------------------------------
| membrane | 001004 | Testing &ResearchInstitute) | |||
|---|---|---|---|---|---|
| Mucosal Irritation | MGK-2022-000223 | ISO 10993-23 | None Irritation | ||
| Skin Sensitization | MGK-2022-000224 | ISO 10993-10 | Do not show anyhypersensitivity | ||
| Acute systemictoxicity | MGK-2022-000225 | ISO 10993-11 | Do not show any acutesystemic toxicity |
(2) Justification for not conducting the Subacute/subchronic toxicity, Genotoxicity, Implantation, Chronic toxicity test
Biological safety was evaluated by conducting tests on cytotoxicity, sensitization irritation or intracutaneous reactivity, acute toxicity depending on contact area and contact duration. But, Subacute/subchronic toxicity, Genotoxicity, Implantation, Chronic toxicity Tests were not conducted due to the reasons as follows;
Subacute/subchronic toxicity, Genotoxicity, Implantation, Chronic toxicity were evaluated through the biological evaluation written by an expert [Seoul National University Dental Hospital Dental Material & Device Evaluation Center]. The Biological Assessment Report (CR2208098) includes the biological evaluation of Subacute/subchronic toxicity, Genotoxicity,
Implantation, Chronic toxicity. Required Subacute/subchronic toxicity, Genotoxicity, Implantation, Chronic toxicity Test have been substituted by the result of this evaluation.
The biocompatibility test results demonstrated no new concern in the cytotoxicity, sensitization, irritation, acute systemic toxicity, subacute/subchronic toxicity, implantation, and chronic toxicity.
The result of the biocompatibility test demonstrates that A-Line Advanced Orthodontic Ceramic bracket is substantially equivalent to the predicate device.
[Performance Testing]
- ISO 27020 Dentistry Brackets and tubes for use in orthodontics
- ISO 22674 Dentistry Metallic materials for fixed and removable restorations and appliances
- ISO 10271 Dentistry Corrosion test methods for metallic materials
- ISO/TS 11405 Dentistry Testing of adhesion to tooth structure
Along with the above biocompatibility testing, Performance Testing has been conducted for A-Line Advanced orthodontic ceramic bracket.
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 A-Line Advanced Orthodontic Ceramic bracket is substantially equivalent to the predicate device.
{6}------------------------------------------------
Therefore, the above discussion made us conclude that A-Line Advanced is substantially equivalent to the predicate devices for its intended use.
4.7 Clinical Test Conclusion
Clinical testing was not required for this submission.
4.8 Technical Characteristics and Substantial Equivalence
The Orthodontic Ceramic bracket(A-Line Advanced) is substantially equivalent to Orthodontic Ceramic bracket(S-Line) (K182193). The following comparison table is presented to demonstrate substantial equivalence.
The Orthodontic Ceramic bracket(A-Line Advanced) does not have a new intended use. It shows equivalent specifications with the predicate devices in most of parameters. However, there are differences in some parameters [Material composition of Bracket, Material composition of Door, Bracket In-out(mm), Bracket Torque( • ), Bracket Angulation( • )] between Orthodontic Ceramic bracket(A-Line Advanced) and Predicate Device(K182193).
As identification dot is to facilitate easy identification for user when locating Orthodontic Ceramic bracket(A-Line Advanced) on teeth, it does not affect effectiveness or safety even though there is a difference in material composition of colorants for bracket placement orientation. In addition, it is confirmed that the difference of Bracket In-out & Bracket Torque & Bracket Angulation does not affect effectiveness or safety through Bench Test(*) between the Orthodontic Ceramic bracket(A-Line Advanced) and Predicate Device.
In almost all aspects, the Orthodontic Ceramic bracket(A-Line Advanced) is substantially equivalent in its effectiveness and safety to the predicate devices.
| Candidate Device | Predicate 1 | SubstantialEquivalenceAnalysis | |
|---|---|---|---|
| 510(k)Number | Pending | K182193 | - |
| Device Name | A-Line Advanced | S-Line | - |
| Common Name | Orthodontic Ceramic bracket | Orthodontic Ceramic bracket | - |
| Manufacturer | BIOCETEC CO., LTD. | BIOCETEC CO., LTD. | - |
| Indication forUse | A-Line Advanced orthodonticceramic bracket is intended to bebonded to a tooth to applypressure to a tooth from aflexible orthodontic wire to alterits position. | S-Line orthodontic ceramicbracket is intended to be bondedto a tooth to apply pressure to atooth from a flexible orthodonticwire to alter its position. | Same as predicate |
| Materialcomposition ofBracket | Polycrystalline Alumina* Primer Polymer : 3-(Trimethoxysilyl)propyl-2-Methyl-2-Propenoic Acid &Acetone | Polycrystalline Alumina | No significantdifference : Thesubject device passedthe test criteria for thebiological evaluationaccording to therecognized consensus |
| standard ISO 10993-1No significant | |||
| Materialcomposition ofDoor | Ni-Co-Cr-Mo Alloy | Polycrystalline Alumina | difference : Thesubject device passedthe test criteria for thebiological evaluationaccording to therecognized consensusstandard ISO 10993-1 |
| Materialcomposition ofcolorants forbracketplacementorientation | Polyvinylpyrrolidone(25wt%)Sweet whey powder(25wt%)TiO2(25wt%)Food dye (25wt%) | Polyvinylpyrrolidone(25wt%)Sweet whey powder(25wt%)TiO2(25wt%)Food dye(25wt%) | Same as predicate |
| Transparency | Half-transparency | Half-transparency | Same as predicate |
| Bracket design | MBT, ROTH designs with andwithout hook, conforming to ISO27020:2010 Dentistry – Bracketsand tube for Use in Orthodontics | MBT, ROTH designs with andwithout hook, conforming to ISO27020:2010 Dentistry - Bracketsand tube for Use in Orthodontics | Same as predicate |
| Self-ligatingmechanism | Yes | Yes | Same as predicate |
| Design parts | Hook, Slot, Round home, baseand marking | Hook, Slot, Round home, baseand marking | Same as predicate |
| Bracket In-out(mm) | 0.7 to 1.24 | 0.65 to 1.08 | No significantdifference : Thesubject device passedthe test criteria for thebench test accordingto the recognizedconsensus standardISO 27020. |
| BracketTorque(°) | -30 to 17 | -22 to +17 | No significantdifference : Thesubject device passedthe test criteria for thebench test accordingto the recognizedconsensus standardISO 27020. |
| BracketAngulation(°) | 0 to 13 | 0 to 11 | No significantdifference : Thesubject device passedthe test criteria for thebench test accordingto the recognizedconsensus standardISO 27020. |
| Available slotsizes | 0.018 / 0.022 inch | 0.018 / 0.022 inch | Same as predicate |
| Orientationmarking | Yes | Yes | Same as predicate |
| Single use | Yes | Yes | Same as predicate |
| Non-SterilePackaging | Yes | Yes | Same as predicate |
| TargetPopulation | Patients in need of teethalignment correction | Patients in need of teethalignment correction | Same as predicate |
| AnatomicalSite | Teeth | Teeth | Same as predicate |
| Location of Use | Use only by professionalorthodontists | Use only by professionalorthodontists | Same as predicate |
| Bio-compatibility | All user directly contactingmaterials are compliance withISO10993 requirements. | All user directly contactingmaterials are compliance withISO10993 requirements. | Same as predicate |
Table 1. General Device Characteristics Comparison Table
{7}------------------------------------------------
Submitter: BIOCETEC CO., LTD.
A-Line Advanced Premarket Notification: Traditional 510(k)
{8}------------------------------------------------
Submitter: BIOCETEC CO., LTD.
(*) Comparison of the property of two orthodontic brackets by bench test
Orthodontic Ceramic bracket(A-Line Advanced) and the predicate device(S-Line (K182193)) have identical indication for use statements and the same intended use.
The 510(K) Documentation also includes data from bench testing to evaluate the performance of Orthodontic Ceramic bracket(A-Line Advanced) to the predicate device. The properties evaluated include wire slot torque test, shear bond strength test, and bracket removal test, wire slot drag test and door pull-out test.
Although the subject device and predicate device are no significant differences in some parameters[Material composition of Bracket, Material composition of Door, Bracket In-out(mm), Bracket Torque( • ), Bracket Angulation( • )], the differences do not affect the substantial equivalence of the subject device when compared to the predicate device.
These differences do not raise different questions of safety or effectiveness.
| 1.9 | Conclusion | Based on the testing results, BIOCETEC CO., LTD. concludes thatthe subject device is substantially equivalent to the predicatedevice. |
|---|---|---|
| 1.10 | Declarations | This summary includes only information that is also covered inthe body of the 510(k).This summary does not contain any puffery or unsubstantiatedlabeling claims. |
§ 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.