(422 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and function of a physical orthodontic bracket, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as moving teeth to improve their alignment, which is a therapeutic purpose.
No
The device, a ceramic bracket for orthodontic movement, is designed to physically move teeth, not to diagnose any condition. Its intended use and description focus on treatment rather than diagnosis.
No
The device description explicitly states it is a "Ceramic Bracket" which is a physical component bonded to teeth. The performance studies also focus on mechanical properties like shear bond strength and torque strength, which are relevant to a physical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "orthodontic movement of natural teeth." This is a mechanical function performed directly on the patient's body (in vivo).
- Device Description: The description clearly states the device is "bonded to natural teeth" and used to "cause tooth movement." This is a physical intervention, not a diagnostic test performed on samples outside the body.
- Lack of Diagnostic Activity: There is no mention of analyzing samples (blood, tissue, etc.) or providing diagnostic information about a patient's health condition.
- Performance Studies: The performance studies focus on mechanical properties like shear bond strength and torque strength, which are relevant to the device's physical function in the mouth, not its ability to diagnose.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or compatibility purposes. This ceramic bracket does not fit that description.
N/A
Intended Use / Indications for Use
Ceramic Bracket is indicated for orthodontic movement of natural teeth.
Product codes (comma separated list FDA assigned to the subject device)
NJM
Device Description
Ceramic bracket are designed to move teeth to improve their alignment. Ceramic bracket are bonded to natural teeth by dental professionals to connect with orthodontic wires to cause tooth movement to a more preferred position. Ceramic bracket are intended for use in affixed to a tooth so that pressure can be exerted on the teeth. Use bonding supplies to bond the bracket on to a tooth. Ceramic bracket are bonded to natural teeth by dental professionals to connect with orthodontic wires to cause tooth movement to a more preferred position.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
natural teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental professionals
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)
Performance testing has been carried out to demonstrate that this device meets the performance specifications for its intend use. The following tests were performed on the device:
· ISO 27020 First edition 2010-12-15 Dentistry - Brackets and Tubes for use in Orthodontics Ceramic Bracket.
The biocompatibility evaluation and testing of the Product name was conducted in accordance with the following standards and guidance, as recognized by the FDA:
- . FDA Draft Guidance - Use of International Standard ISO- 10993, "Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing", dated 04-23-2013
- . ISO 10993-3,Biological evaluation of medical device-Part 3: Test for genotoxicity, carcinogenicity and reproductive toxicity.
- . ISO 10993-5, Biological evaluation of medical device-Part 5: Tests for in vitro cytotoxicity.
- . ISO 10993-10. Biological evaluation of medical device-Part 10: Tests for irritation and skin sensitization.
- ISO 10993-11, Biological evaluation of medical device-Part 11: Tests for systemic toxicity.
- . ISO 10993-12, Biological evaluation of medical device-Part 12: Sample preparation and reference materials.
Ceramic bracket's mechanical function including Shear Bond Strength, Torque Strength test and structure integrity were tested. The results were compared to recognized standards (ISO 6872:2015, ISO 29022:2013, ISO 27020:2010, ISO 6474-2:2012) and clinical literature data to demonstrate substantial equivalence.
No animal studies or clinical testing have been required for these devices.
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.
0
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.
June 7, 2019
MEM Dental Technology Co., Ltd Anita Chen Official Correspondent 2F., No.22, Ln.31, Sec.1, Huandong Rd., Xinshi Dist. Tainan City, 74146 Tw
Re: K180952
Trade/Device Name: Ceramic Bracket Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NJM Dated: April 20, 2019 Received: May 6, 2019
Dear Anita Chen:
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
1
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 (OS) 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,
Srinivas Nandkumar, Ph.D. 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
2
Indications for Use
510(k) Number (if known) K180952
Device Name Ceramic Bracket
Indications for Use (Describe)
Ceramic Bracket is indicated for orthodontic movement of natural teeth.
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 510(k) summary information is submitted as part of the Premarket Notification in compliance with requirements of CFR Part 807, Subpart E and Section 807.92
| The assigned 510(k) Number: | K180952 | |
|---|---|---|
| 1. | Submitter | |
| Mailing Address | MEM Dental Technology Co., Ltd | |
| 2F., No.22, Ln.31, Sec.1, Huandong Rd., | ||
| Xinshi Dist., Tainan City 74146, Taiwan | ||
| Phone: +886 6 5053939 | ||
| Establishment Registration No.: 3009011037 | ||
| Contact Person | Anita Chen | |
| Phone: | +886(0) 939-855-759 | |
| Fax: | +886 6 5051212 | |
| E-mail: | m9104303@gmail.com | |
| Date Prepared | 2019.06.06 |
- Device Name 2
| Proprietary Name: | Ceramic Bracket |
|---|---|
| Common or Usual Name | Bracket, Ceramic, Orthodontic |
| Classification Name | Bracket Orthodontic Plastic Bracket (21 CFR |
| 872.5470) | |
| Product Code | NJM |
| Device | Ceramic Bracket |
| CFR Classification | CFR Part 872.5470 |
| Device Class | II |
| Classification Panel | Dental |
| Primary Predicate | |
| 510(k) number | K160615 |
3
4
| Device name | Orthodontic Ceramic Brackets 1.1 |
|---|---|
| Manufacturer | TOMY, INC |
| 6 tenko blg. 3-16-7 | |
| midoricho, fuchu city, JP 183-0006 | |
| 4 Device Description | Ceramic bracket are designed to move teeth to |
| improve their alignment. Ceramic bracket are bonded | |
| to natural teeth by dental professionals to connect | |
| with orthodontic wires to cause tooth movement to a | |
| more preferred position. |
Ceramic bracket are intended for use in affixed to a
tooth so that pressure can be exerted on the teeth. Use
bonding supplies to bond the bracket on to a tooth.
Use bonding supplies to bond the bracket on to a
tooth. Ceramic bracket are bonded to natural teeth
by dental professionals to connect with orthodontic
wires to cause tooth movement to a more preferred
position. |
| 5. Indication for Use: | Ceramic bracket is indicated for orthodontic
movement of natural teeth. |
| 6. Technological | A comparison of the device features, intended use, |
|---|---|
| Characteristics and | and other information demonstrates that the |
| Substantial Equivalence | Ceramic bracket is substantially equivalent to the |
| Comparison with Predicate: | predicate device as summarized in Table 1. |
Table 1
5
| Manufacturer | MEM Dental Technology Co., Ltd. | Tomy, Inc. |
|---|---|---|
| Subject Device | Primary Predicate Device | |
| Device name | Ceramic bracket | Orthodontic Ceramic Brackets 1.1 |
| 510(k) Number | K180952 | K160615 |
| Indication for Use | Ceramic bracket is indicated for | |
| orthodontic movement of | ||
| natural teeth. | Orthodontic Ceramic Brackets | |
| 1.1 are indicated for orthodontic | ||
| movement of natural teeth. | ||
| Classification name | Orthodontic Plastic Bracket | Orthodontic Plastic Bracket |
| Rag Number | 872.5470 | 872.5470 |
| Product Code | NJM | NJM |
| Class | II | II |
| Medical Specialty | Dental | Dental |
| Ligation | Non-Self-Ligating | Non-Self-Ligating |
| Self-Ligating | Self-Ligating | |
| Base | Mechanical Lock Base | Mechanical Lock Base |
| Sterility | Non-Sterile | Non-Sterile |
| Materials | Polycrystalline (translucent) alumina | Polycrystalline (translucent) alumina |
| Utility | Single-use only | Single-use only |
| Design | Archwire slot, tiewings for ligature and | |
| identification marks for placement | ||
| Hooks for ligation, for additional tooth | ||
| movement | ||
| Molded ceramic body with rounded | ||
| corners and e Slot to hold orthodontic | ||
| wires edges | Archwire slot, tiewings for ligature and | |
| identification marks for placement | ||
| Hooks for ligation, for additional tooth | ||
| movement | ||
| Molded ceramic body with rounded | ||
| corners and e Slot to hold orthodontic | ||
| wires edges |
6
| Manufacturer | MEM Dental Technology Co., Ltd. | Tomy, Inc. |
|---|---|---|
| Subject Device | Primary Predicate Device | |
| Device name | Ceramic bracket | Orthodontic Ceramic Brackets 1.1 |
| 510(k) Number | K180952 | K160615 |
| Picture of Device | Image: Non-Self-Ligating | |
| Image: Self-Ligating | Image: Non-Self-Ligating Mandibular Bicuspid | |
| Image: Non-Self-Ligating for all other Teeth | ||
| Image: Self-Ligating Mandibular Bicuspid | ||
| Image: Self-Ligating for all other Teeth |
7. Performance Testing
Performance testing has been carried out to demonstrate that this device meets the performance specifications for its intend use. The following tests were performed on the device:
· ISO 27020 First edition 2010-12-15 Dentistry - Brackets and Tubes for use in Orthodontics
Ceramic Bracket.
All of the components found in the Ceramic Bracket have been used in legally marketed devices, such as the primary predicate Orthodontic Ceramic Brackets 1.1.
Biocompatibility Testing
7
The biocompatibility evaluation and testing of the Product name was conducted in accordance with the following standards and guidance, as recognized by the FDA:
- . FDA Draft Guidance - Use of International Standard ISO- 10993, "Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing", dated 04-23-2013
- . ISO 10993-3,Biological evaluation of medical device-Part 3: Test for genotoxicity, carcinogenicity and reproductive toxicity.
- . ISO 10993-5, Biological evaluation of medical device-Part 5: Tests for in vitro cytotoxicity.
- . ISO 10993-10. Biological evaluation of medical device-Part 10: Tests for irritation and skin sensitization.
- ISO 10993-11, Biological evaluation of medical device-Part 11: Tests for systemic toxicity.
- . ISO 10993-12, Biological evaluation of medical device-Part 12: Sample preparation and reference materials.
Sterilization Status
The Ceramic Bracket are provided non-sterile and are not processed prior to use.
Mechanical testing
Ceramic bracket's mechanical function including Shear Bond Strength, Torque Strength test and structure integrity were tested. The results were compared to recognized standards (ISO 6872:2015, ISO 29022:2013, ISO 27020:2010, ISO 6474-2:2012) and clinical literature data to demonstrate substantial equivalence.
No animal studies or clinical testing have been required for these devices.
8. Conclusion
Based on the intended use and/or indications for use, technological characteristics, performance testing and comparison to the predicate device, the Ceramic bracket is substantially equivalent.