(415 days)
Not Found
No
The device description and performance studies focus on the physical properties and mechanical function of an orthodontic bracket, with no mention of AI or ML technologies.
Yes
The device is described as an orthodontic bracket used for the "orthodontic movement of teeth" to "recover aesthetics and function of malocclusion" and "straighten irregular teeth." This aligns with the definition of a therapeutic device as it is intended to treat a medical condition (malocclusion) to improve health and function.
No
The device is an orthodontic bracket used for the physical movement of teeth to correct malocclusion, not for diagnosing conditions.
No
The device description clearly states it is a physical orthodontic bracket made of aluminum oxide, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for the orthodontic movement of teeth." This is a mechanical action performed directly on the patient's teeth.
- Device Description: The description details a physical bracket attached to teeth to straighten them using orthodontic wire. This is a physical device for mechanical manipulation.
- Lack of In Vitro Testing: The description of performance studies mentions testing related to mechanical properties (adhesive strength, design characteristics) and risk analysis. There is no mention of testing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such samples.
- Anatomical Site: The anatomical site is "teeth," which are part of the patient's body, not a sample taken from the body for analysis.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such function. It is a medical device used for physical treatment.
N/A
Intended Use / Indications for Use
This device is intended for the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. The devices are intended to be single use only
Product codes
NJM
Device Description
Orthodontic Ceramic bracket, ROSA Bracket is an orthodontic bracket attached to teeth to recover aesthetics and function of malocclusion. Made with aluminum oxide, it is attached to teeth and straightens irregular teeth with orthodontic wire installed through the wire's elasticity. It is made with aluminum oxide and seeks smooth movement of orthodontic wire for straightening irregular teeth and it requires additional rubber ring or ligating wire to fix Wire. It consists of three parts: the first part is the slot for the orthodontic wire; the second part is a round groove that is to hold a wire with an elastic "O" ring; the third part is the base that adheres to the tooth surface. A colored marking on wing part of bracket indicates orientation for placement.
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
Not Found
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)
Biocompatibility testing including cytotoxicity, sensitization, oral mucosal irritation was completed according to the following standards: ISO 10993-1 Biological Evaluation of Medical Devices –Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process ISO 10993-5 Biological Evaluation of Medical Devices – Part 5 Cytotoxicity ISO 10993-10 Biological Evaluation of Medical Devices Part 10: Tests for irritation and skin sensitization ISO 10993-12 Biological evaluation of medical devices -- Part 12: Sample preparation and reference materials
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; A risk analysis was conducted based on ISO 14971:2012 Medical devices – Application of risk management to medical devices.
No clinical performance testing was performed on ROSA brackets.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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.
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November 15, 2019
GNI Co., LTD % Sang Myung Regualtory Affair Consultant E&M Consulting D-1474ho, 230 Simin-daero, Dongan-gu Anyang, 14067 Kr
Re: K182672
Trade/Device Name: ROSA Bracket Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NJM Dated: October 7, 2019 Received: October 19, 2018
Dear Sang Myung:
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
1
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 medical devices and radiation-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,
for Srinivas Nandkumar, Ph.D. Acting Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K182672
Device Name ROSA Bracket
Indications for Use (Describe)
This device is intended for the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. The devices are intended to be single use only
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image is a logo for GNI, which is written in a bold, dark blue font. To the left of the name is a graphic of four squares, two white and two colored. The bottom left square is dark blue, and the bottom right square is red. Underneath the name is the slogan "The Best Quality & Service".
GNI Co., LTD
510(k) Summary
K182672
This summary of 510(k) Safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
GNI Co., LTD Submitter: 5F, 501: 5F 501, 63-12 Dongtancheomdansaneop 1-RO Hwaseong-si, Gyeonggido, 18469, South Korea Telephone: +82-505-600-8880 Fax: -82-505-333-8880 E-mail: admin 02@ggniortho.com
Contact Person: Regulatory Affair/Sang Hwa Myung Telephone: +82-10-4952-6638 E-mail: mshenmc@gmail.com
Date 510(k) summary prepared: October 7, 2018
Trade Name: ROSA Bracket Common Name: Orthodontic Ceramic Brackets Classification Name: Orthodontic plastic bracket Classification: Class II Product Code: NJM Classification Panel: Dental Regulation Numbers: 21 CFR 872.5470 Type of 510(k) submission: Traditional
Description of Device:
Orthodontic Ceramic bracket, ROSA Bracket is an orthodontic bracket attached to teeth to recover aesthetics and function of malocclusion. Made with aluminum oxide, it is attached to teeth and straightens irregular teeth with orthodontic wire installed through the wire's elasticity. It is made with aluminum oxide and seeks smooth movement of orthodontic wire for straightening irregular teeth and it requires additional rubber ring or ligating wire to fix Wire. It consists of three parts: the first part is the slot for the orthodontic wire; the second part is a round groove that is to hold a wire with an elastic "O" ring; the third part is the base that adheres to the tooth surface. A colored marking on wing part of bracket indicates orientation for placement.
Indication for use: This device is intended for the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. The devices are intended to be single use only
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Predicate Device
Primary Manufacturer: Speed Dental Co., Ltd 510(k) Number: K150141 Trade Name: Orthodontics Bracket Common Name: Orthodontic Ceramic Brackets Requlation Name: Orthodontic Plastic Bracket Regulation Numbers: 21 CFR 872.5470 Product Code: NJM Classification: Class II
Substantial Equivalence:
Comparison table is as follows.
Table 1: Substantial equivalence comparison
| Manufacturer | GNI Co., LTD | Speed Dental Co., Ltd |
|---|---|---|
| 510(k)Number | K182672 | K150141 |
| Common Name | Orthodontic Ceramic Brackets | Orthodontic Ceramic Brackets |
| Trade Name | ROSA Bracket | Orthodontics Bracket |
| Indication for Use | This device is intended for the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. The devices are intended to be single use only | This device is intended for the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. The devices are intended to be single use only |
| Target Population | Patients in need of teeth alignment correction | Patients in need of teeth alignment correction |
| Material | Aluminum Oxide | Aluminum Oxide |
| Biocompatibility | Meets the applicable requirement of ISO 10993 | Meets the applicable requirement of ISO 10993 |
| Transparency | Half-transparency | Half-transparency |
| Design | Hook, Slot, Round home, base and marking | Hook, Slot, Round home, base and marking |
| Maxillary In-out(mm) | 1.0-1.2 | 1.04-1.19 |
| Maxillary Torque (°) | -7 to +17 | -7 to +17 |
| Maxillary Angulation | 0-11 | 0-10 |
| Slot Size | 0.022 inch | 0.022 inch |
| orientation marking | Colored dot on external surface | Colored dot on external surface |
| Single Use | YES | YES |
| Non-sterile | YES | YES |
Information provided in these 510(k) submissions shows that ROSA Brackets are substantially equivalent to the predicate devices in terms of indication for use, device design and performance that related with technological characteristics.
Differences between the proposed and predicate devices are not expected to affect the overall performance of the device. These differences include slight variations in design such as maxillary angulation and In-Out. While the ranges are not identical, they are still within the range of what is typically observed for orthodontic brackets. These differences do not raise different questions of safety or effectiveness.
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Biocompatibility testing:
Biocompatibility testing including cytotoxicity, sensitization, oral mucosal irritation was completed according to the following standards: ISO 10993-1 Biological Evaluation of Medical Devices –Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process ISO 10993-5 Biological Evaluation of Medical Devices – Part 5 Cytotoxicity ISO 10993-10 Biological Evaluation of Medical Devices Part 10: Tests for irritation and skin sensitization ISO 10993-12 Biological evaluation of medical devices -- Part 12: Sample preparation and reference materials
Non-clinical Performance Data:
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; A risk analysis was conducted based on ISO 14971:2012 Medical devices – Application of risk management to medical devices.
Clinical Data:
No clinical performance testing was performed on ROSA brackets.
Conclusion
The Rosa Bracket has the same device characteristics as the predicate device, based on the information provided in this summary. We conclude that Rosa Bracket is substantially equivalent to the predicate device of Orthodontics Bracket. (K150141)