(422 days)
Ceramic Bracket is indicated for orthodontic movement of natural teeth.
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.
This is a 510(k) premarket notification for a medical device called "Ceramic Bracket." The document describes the device, its intended use, and argues for its substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and the study provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a numerical or pass/fail threshold manner, as might be seen for diagnostic device performance. Instead, it relies on demonstrating compliance with relevant ISO standards and comparability to the predicate device. The device is a physical orthodontic bracket, not a diagnostic algorithm.
Therefore, I will present the performance tests conducted and the general conclusion for device acceptance.
| Acceptance Criteria (Implied by Standards) | Reported Device Performance |
|---|---|
| Compliance with ISO 27020 (General Orthodontic Brackets) | Device meets performance specifications of ISO 27020:2010 |
| Biocompatibility | Evaluated and tested according to ISO 10993 standards: - ISO 10993-3 (Genotoxicity, Carcinogenicity, Reproductive toxicity) - ISO 10993-5 (In vitro cytotoxicity) - ISO 10993-10 (Irritation and skin sensitization) - ISO 10993-11 (Systemic toxicity) - ISO 10993-12 (Sample preparation and reference materials) |
| Mechanical Function (Shear Bond Strength) | Tested, results compared to ISO 6872:2015, ISO 29022:2013, ISO 27020:2010, ISO 6474-2:2012, and clinical literature data. |
| Mechanical Function (Torque Strength) | Tested, results compared to ISO 6872:2015, ISO 29022:2013, ISO 27020:2010, ISO 6474-2:2012, and clinical literature data. |
| Structural Integrity | Tested, results compared to ISO 6872:2015, ISO 29022:2013, ISO 27020:2010, ISO 6474-2:2012, and clinical literature data. |
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not specify the exact sample sizes used for each mechanical or biocompatibility test. It indicates that "Performance testing has been carried out to demonstrate that this device meets the performance specifications for its intend use" and lists the types of tests.
- Data Provenance: Not specified in terms of country of origin. The testing was conducted to comply with international ISO standards, suggesting tests were performed in accordance with these globally recognized methodologies. The testing appears to be based on physical device samples rather than clinical data sets. It is a retrospective evaluation against established standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to this type of device and study. The "ground truth" for a physical device like an orthodontic bracket is its physical and biological performance as measured against engineering and biocompatibility standards, not an expert-annotated dataset. The standards themselves are developed by expert consensus in the relevant fields (dentistry, materials science, biocompatibility).
4. Adjudication method for the test set
Not applicable. The "test set" here refers to physical samples of the device being evaluated through standardized laboratory tests, not a dataset requiring human adjudication.
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 device is an orthodontic bracket, not an AI-powered diagnostic tool. Therefore, no MRMC study or AI assistance evaluation was performed or required.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an orthodontic bracket, not an algorithm.
7. The type of ground truth used
The "ground truth" for this device's performance evaluation is established by:
- International Standards: Specific ISO standards (e.g., ISO 27020, ISO 6872, ISO 29022, ISO 6474-2 for mechanical properties; ISO 10993 series for biocompatibility).
- Clinical Literature Data: Used as a reference for comparison in mechanical testing.
Essentially, the device's characteristics are measured and compared against predefined thresholds and benchmarks set by these standards and literature, rather than against a human expert's "ground truth" for a case.
8. The sample size for the training set
Not applicable. Since this is a physical medical device and not an AI/algorithm, there is no "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
{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) |
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
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 CFR872.5470) |
| 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, INC6 tenko blg. 3-16-7midoricho, fuchu city, JP 183-0006 |
| 4 Device Description | Ceramic bracket are designed to move teeth toimprove their alignment. Ceramic bracket are bondedto natural teeth by dental professionals to connectwith orthodontic wires to cause tooth movement to amore preferred position.Ceramic bracket are intended for use in affixed to atooth so that pressure can be exerted on the teeth. Usebonding supplies to bond the bracket on to a tooth.Use bonding supplies to bond the bracket on to atooth. Ceramic bracket are bonded to natural teethby dental professionals to connect with orthodonticwires to cause tooth movement to a more preferredposition. |
| 5. Indication for Use: | Ceramic bracket is indicated for orthodonticmovement 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 fororthodontic movement ofnatural teeth. | Orthodontic Ceramic Brackets1.1 are indicated for orthodonticmovement 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 andidentification marks for placementHooks for ligation, for additional toothmovementMolded ceramic body with roundedcorners and e Slot to hold orthodonticwires edges | Archwire slot, tiewings for ligature andidentification marks for placementHooks for ligation, for additional toothmovementMolded ceramic body with roundedcorners and e Slot to hold orthodonticwires 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-LigatingImage: Self-Ligating | Image: Non-Self-Ligating Mandibular BicuspidImage: Non-Self-Ligating for all other TeethImage: Self-Ligating Mandibular BicuspidImage: 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.
§ 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.