(288 days)
Not Found
No
The description focuses on the physical components and materials of a traditional orthodontic bracket and does not mention any software, algorithms, or data processing that would indicate AI/ML.
Yes
Explanation: 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." These actions directly treat a medical condition (malocclusion/irregular teeth) to restore function and aesthetics, classifying it as a therapeutic device.
No
The device is an orthodontic bracket used for the physical movement and straightening of teeth, 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 clearly stated as "for the orthodontic movement of teeth." This is a mechanical function performed directly on the patient's teeth.
- Device Description: The description details a physical bracket attached to teeth to apply force and straighten them. This is a physical intervention, not a test performed on a sample from the body.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing samples from the human body (blood, urine, tissue, etc.).
- Providing information about a physiological state, disease, or condition.
- Using reagents or calibrators.
- Performing a test in a laboratory setting.
The device is a medical device used for orthodontic treatment, which is a form of physical therapy to correct the alignment of teeth. It does not fit the definition of an In Vitro Diagnostic device.
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 (comma separated list FDA assigned to the subject device)
NJM
Device Description
Orthodontic Ceramic bracket, VENUS and ROSE 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 irreqular teeth and it requires additional rubber ring or ligating wire to fix Wire.
VENUS Bracket no hook type and ROSE bracket have 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.
VENUS Bracket with hook type consist five parts: the slot for 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; forth part is open guide part which serves as a path for movement of device used to open cap ligated to body; last part is different part from other type of models, it has self-ligating Clip to fix the teeth.
These devices are designed for orthodontic use only. The devices intended use for single use only.
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)
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: Dentistry - Metallic materials for fixed and removable restorations and appliances with ISO 22674:2016; Dentistry-Corrosion test methods for metallic materials with ISO 10271:2011; 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 VENUS and ROSE 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.
Not Found
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.
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Image /page/0/Picture/0 description: The image shows 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.
March 12, 2021
GNI Co., LTD % Sang Myung Regulatory Affair Specialist E&M D-1474ho, 230 Simin-daero, Dongan-gu Anyang, Gyeonggi-do 14067 Republic of Korea
Re: K201410
Trade/Device Name: VENUS Bracket, ROSE Bracket Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NJM Dated: December 3, 2020 Received: December 14, 2020
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,
Michael E. Adjodha, M.ChE. Assistant 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name VENUS Bracket; ROSE 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) |
|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Image /page/3/Picture/0 description: The image shows the logo for GNI. The logo consists of four squares in the upper left corner, with the top two squares being white and the bottom left square being dark blue and the bottom right square being red. To the right of the squares is the text "GNI" in dark blue, with the "I" having a red triangle above it. Below the logo is the text "The Best Quality & Service" in a smaller font.
GNI Co., LTD
510(k) Summary
K201410
This summary of 510(k) substantial equivalence information is being submitted in accordance with the requirements of 21 CFR 807.92.
Submitter: GNI Co., LTD 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: +82-70-7807-0550 FAX: +82-31-388-9263 E-mail: mshenmc@gmail.com
Date 510(k) summary prepared: Feb 5th, 2021
Trade Name: VENUS Bracket; ROSE 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, VENUS and ROSE 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 irreqular teeth and it requires additional rubber ring or ligating wire to fix Wire.
VENUS Bracket no hook type and ROSE bracket have 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.
VENUS Bracket with hook type consist five parts: the slot for 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; forth part is open guide part which serves as a path for movement of device used to open cap ligated to body; last part is different part from other type of models, it has self-ligating Clip to fix the teeth.
4
These devices are designed for orthodontic use only. The devices intended use for single use only.
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
Primary Predicate Device:
Primary Manufacturer: GNI Co., LTD 510(k) Number: K182672 Trade Name: ROSA Bracket Common Name: Orthodontic Ceramic Brackets Regulation 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
A. VENUS and ROSE Bracket
| Contents | Subject Device | Predicate Device |
|---|---|---|
| Manufacturer | GNI Co., LTD | GNI Co., LTD |
| 510(k)Number | K201410 | K182672 |
| Common Name | Orthodontic Ceramic Brackets | Orthodontic Ceramic Brackets |
| Trade Name | VENUS Bracket, | |
| ROSE Bracket | ROSA 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 |
| Type of Aluminum Oxide | Polycrystalline | Monocrystalline |
| 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, self-ligating Clip and | ||
| marking | Hook, Slot, Round home, | |
| base and marking | ||
| Maxillary In-out(mm) | 1.0 - 1.2 | 1.0 - 1.2 |
| Maxillary Torque (°) | -7 to +17 | -7 to +17 |
| Maxillary Angulation | 0 - 11 | 0 - 11 |
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| Slot Size | 0.018/0.022 inch | 0.022 inch |
|---|---|---|
| orientation marking | Colored dot on external surface | Colored dot on external surface |
| Single Use | YES | YES |
| Non-sterile | YES | YES |
VENUS and ROSE Bracket have substantially equivalent Indications for Use as the identified predicate devices. The VENUS bracket has self-ligating Clip design and it is different design of predicate device; however, these slight differences do not alter the intended therapeutic use of the device as compared to the predicates.
The technological characteristics, how the device functions, and the mechanical properties of VENUS and ROSE compared to the predicates have not fundamentally changed. Orthodontic brackets are designed to be affixed to teeth and to hold an arch wire so that pressure can be exerted to move the teeth to new positions.
The subject device material made by polycrystalline aluminum oxide and predicate device material made by monocrystalline aluminum oxide. Also, the slot size 0.018inch added to subject device.
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: Dentistry - Metallic materials for fixed and removable restorations and appliances with ISO 22674:2016; Dentistry-Corrosion test methods for metallic materials with ISO 10271:2011; 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 VENUS and ROSE brackets.
Conclusion
The VENUS and ROSE Bracket has the same device characteristics as the predicate device (ROSA Bracket), based on the information provided in this summary we conclude that VENUS and ROSE Bracket is substantially equivalent to the predicate device of Orthodontics Bracket. (K182672)