(329 days)
Not Found
No
The description focuses on the physical manufacturing process and software for treatment planning, without mentioning AI/ML for analysis or decision-making.
Yes
The device, Clear Aligners, is designed to align permanent teeth through orthodontic treatment to correct misalignment and malocclusion, directly addressing a health condition.
No
The device is an orthodontic treatment device used for the alignment of teeth, not for diagnosing any medical condition. It moves teeth to a desired position rather than identifying or characterizing a disease or condition.
No
The device description clearly states that the device is an intraoral thermoformed plastic aligner, which is a physical hardware component. While software is used in the manufacturing process, the final device is not software-only.
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 "alignment of permanent teeth... through orthodontic treatment of misalignment and malocclusion." This describes a therapeutic intervention on the patient's body, not a diagnostic test performed on a sample taken from the body.
- Device Description: The device is an "intraoral thermoformed plastic aligner" that is worn by the patient. It is a physical device used to apply force to teeth.
- Lack of Diagnostic Function: The description focuses on the process of creating the aligners based on patient data (scans or impressions) and a treatment plan. There is no mention of the device being used to diagnose a condition or provide information about a patient's health status based on in vitro analysis.
- Anatomical Site: The device acts on "permanent teeth," which is a part of the patient's body, not a sample taken from the body.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Clear Aligners indicated for use in the alignment of permanent teeth (i.e. all second molars) through orthodontic treatment of misalignment and malocclusion.
Product codes (comma separated list FDA assigned to the subject device)
NXC
Device Description
The Clear Aligners are intraoral thermoformed plastic aligners that are worn 22 hours per day and are designed to be used in a sequence, each aligner providing a gentle continuous force, to allow for the movement of teeth to the final desired position. The aligners are to be removed for eating and for cleaning.
The Clear Aligners are fabricated using a three-step process.
The first step is to obtain the dimensions and details of the patient's baseline dentition. This is generally done using an oral scan data or a physical impression. This scanned data (digital CAD/CAM models or patient models) are imported into specialized dental software for treatment planning.
The second step is the printing of 3D models of the treatment plan for use in step 3 (thermoforming). In the second step, the doctor utilizes a software application to plan the treatment by creating a series of sequential models that gradually position the their final desired position. A 3D printer is used to create the molds needed for each treatment step to provide the surface around which the aligner is thermoformed.
The final step is the thermoforming of a plastic sheet material to each of the sequential treatment steps. This process is done using a standard thermoforming equipment and the appropriate material as outlined in this submission.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
oral scan data or a physical impression
Anatomical Site
permanent teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental practitioner
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 tests have been conducted to verify that the Clear Aligner meets all design specifications which supports the conclusion that it's Substantially Equivalent (SE) to the predicate device.
Manufacturing Validation Accuracy Testing:
A manufacturing validation was performed to demonstrate the manufacturing process for Clear Aligner. Three critical aspects of the manufacturing process were assessed: digital dentition models from treatment planning, 3D printed molds, and the final thermoformed aligner.
An independent 3rd party software and digital calipers were used to perform point-to-point measurement. All translational measurements were within 0.3mm of the target input value, the predefined tolerance of the manufacturing process. There were no statistical differences in the difference in the intended and measured values observed from any of the groups. This test has met the pre-established acceptance criteria.
The results of the manufacturing validation accuracy testing support a determination of substantial equivalence.
Biocompatibility Testing:
The biocompatibility evaluation for the device was conducted in accordance with "Use of International Standard ISO 10993-1, Biological evaluation and testing within a risk management process -Guidance for Industry and Food and Drug Administration Staff" as recognized by FDA. The Clear aligner is considered surface contacting for a duration of greater than 30 days. The testing included the following tests: Cytotoxicity, Irritation, Sensitization.
The results of the testing met the requirements of the study protocol and the material is considered non-cytotoxic, non-sensitizing and is not an intracutaneous irritant. The results of the studies further support a determination of substantial equivalence.
Clinical Test:
No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
All translational measurements were within 0.3mm of the target input value, the predefined tolerance of the manufacturing process.
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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
Shenzhen Meiming Dentistry Technology Co., Ltd Fei Hu Manager Floor 3, Buliding D. Fuxinlin Industrial Park, Mati Pond, Gushu Community, Xixiang Street, Baoan Dis Shenzhen, Guangdong 518102 China
Re: K213026
Trade/Device Name: Clear Aligner Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: July 7, 2022 Received: July 18, 2022
Dear Fei Hu:
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.
August 16, 2022
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,
For 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 Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K213026
Device Name Clear Aligner
Indications for Use (Describe)
The Clear Aligners indicated for use in the alignment of permanent teeth (i.e. all second molars) through orthodontic treatment of misalignment and malocclusion.
| 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
510(k) number: K213026 Date of Summary Preparation: August 15, 2022
Applicant
Name: Shenzhen Meiming Dentistry Technology Co., Ltd Address: Floor 3, Building D, Fuxinlin industrial park, Mati pond, Gushu community, Xixiang street, Baoan district, Shenzhen, Guangdong, China Official Contact Person Information Name: Fei Hu Tel: 0086- 13219006323 Mail: shenzhenmeiming@gmail.com
Device
| Trade name: | Clear Aligner |
|---|---|
| ------------- | --------------- |
| Common name: | Aligner, Sequential |
|---|---|
| Classification name: | Aligner, Sequential |
| Regulation Medical Specialty Dental | |
| Regulation Number | 872.5470 |
| Product Code | NXC |
| Classification | Class II |
Predicate device
510 (K) Number: K201450 Straight T Clear Dental Aligner Produced by Straight T, Inc.
Indication for use:
The Clear Aligners indicated for use in the alignment teeth (i.e. all second molars) through orthodontic treatment of misalignment and malocclusion.
Device Description
The Clear Aligners are intraoral thermoformed plastic aligners that are worn 22 hours per day and are designed to be used in a sequence, each aligner providing a gentle continuous force, to allow for the movement of teeth to the final desired position. The aligners are to be removed for eating and for cleaning.
The Clear Aligners are fabricated using a three-step process.
The first step is to obtain the dimensions and details of the patient's baseline dentition. This is
4
generally done using an oral scan data or a physical impression. This scanned data (digital CAD/CAM models or patient models) are imported into specialized dental software for treatment planning.
The second step is the printing of 3D models of the treatment plan for use in step 3 (thermoforming). In the second step, the doctor utilizes a software application to plan the treatment by creating a series of sequential models that gradually position the their final desired position. A 3D printer is used to create the molds needed for each treatment step to provide the surface around which the aligner is thermoformed.
The final step is the thermoforming of a plastic sheet material to each of the sequential treatment steps. This process is done using a standard thermoforming equipment and the appropriate material as outlined in this submission.
Software Description
Specialized orthodontic CAD/CAM software will be used to develop the treatment plans and to produce standard 3D printer files that will facilitate the manufacturing of each sequential aligner in the treatment plan. The software application used for the manufacturing validation in this submission is the 3Shape®.
Mechanism of Action
In the same manner as the predicate device, each aligner exerts gentle force to achieve progressive realignment of the teeth until the final correction has been attained. This is based on the treatment plan and proceeds over time.
Comparison with predicate
A summary comparison of features is provided in the following Table:
| Device | New Device
(K213026) | Predicate Device Straight
T Clear Dental Aligner
(K201450) | Comparison |
|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Manufacturer | Shenzhen Meiming
Dentistry Technology
Co., Ltd | Straight T, Inc. | NA |
| Indication for use | The Clear Aligners
indicated for use in the
alignment of permanent
teeth (i.e. all second
molars) through
orthodontic treatment of
misalignment and
malocclusion. | The Straight T Clear
Dental Aligner
Is indicated for use in the
alignment of permanent
teeth (i e all second mol
ars) through orthodont ic
treatment of
misalignment and
malocclusion. | Same |
| Method of use | Each preformed plastic
tray is worn by the
patient as prescribed by | Each preformed plastic
tray is worn by the
patient as prescribed by | Same |
5
| | the dental practitioner,
usually a few weeks prior
to using the next
sequential aligners tray. | the dental practitioner,
usually a few weeks prior
to using the next
sequential aligners tray. | |
|---------------|---------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|------|
| Biocompatible | Yes | Yes | Same |
| OTC or Rx | Rx | Rx | Same |
| Software Use | Yes, 3Shape K180491 | Yes, 3Shape K180491 | Same |
| Sterile | No | No | Same |
There are no differences identified between new device and the predicate device for intended use, mode of action, method of use, material, biocompatibility and software, etc, thus they are substantial equivalent.
Non-clinical Test
Non-clinical tests have been conducted to verify that the Clear Aligner meets all design specifications which supports the conclusion that it's Substantially Equivalent (SE) to the predicate device.
Manufacturing validation accuracy testing
A manufacturing validation was performed to demonstrate the manufacturing process for Clear Aligner. Three critical aspects of the manufacturing process were assessed: digital dentition models from treatment planning, 3D printed molds, and the final thermoformed aligner.
An independent 3rd party software and digital calipers were used to perform point-to-point measurement. All translational measurements were within 0.3mm of the target input value, the predefined tolerance of the manufacturing process. There were no statistical differences in the difference in the intended and measured values observed from any of the groups. This test has met the pre-established acceptance criteria.
The results of the manufacturing validation accuracy testing support a determination of substantial equivalence.
Biocompatibility Testing
The biocompatibility evaluation for the device was conducted in accordance with "Use of International Standard ISO 10993-1, Biological evaluation and testing within a risk management process -Guidance for Industry and Food and Drug Administration Staff" as recognized by FDA. The Clear aligner is considered surface contacting for a duration of greater than 30 days. The testing included the following tests:
- Cytotoxicity
- Irritation
- Sensitization
The results of the testing met the requirements of the study protocol and the material is considered non-cytotoxic, non-sensitizing and is not an intracutaneous irritant. The results of the studies further support a determination of substantial equivalence.
6
Clinical Test
No clinical study is included in this submission.
Conclusion:
The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission K213026, Clear Aligner is as safe, as effective, and performs as well as the legally marketed predicate device cleared under K201450.