(66 days)
No
The summary describes a physical device (clear aligners) and its mechanical properties. There is no mention of AI/ML in the device description, intended use, or performance studies. The input is physical/optical measurements, not images processed by AI/ML.
Yes.
The device is used for the "treatment of tooth malocclusions," which directly addresses a medical condition (malocclusion) to improve health and function.
No
The device is indicated for the treatment of tooth malocclusions, meaning it is a therapeutic device, not a diagnostic one. It corrects problems rather than identifying them.
No
The device description explicitly states it is a "series of clear plastic aligners," which are physical, non-software components. The performance studies also focus on physical properties of the material.
Based on the provided information, the TRIOCLEAR System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- TRIOCLEAR's Function: The TRIOCLEAR System is a physical device (clear plastic aligners) used to mechanically move teeth to correct malocclusions. It directly interacts with the patient's teeth and does not analyze biological specimens.
- Intended Use: The intended use is for the "treatment of tooth malocclusions," which is a therapeutic application, not a diagnostic one.
- Device Description: The description focuses on the physical nature of the aligners and their function in correcting tooth position.
- Input: The input is "physical or optical measurements of the patient's teeth," which are used for designing the aligners, not for analyzing biological samples.
Therefore, the TRIOCLEAR System falls under the category of a medical device used for treatment, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The TRIOCLEAR System is a series of clear, lightweight, plastic appliances indicated for the treatment of tooth malocclusions in patients with permanent dentition (i.e. all second molars). Utilizing a series of increment, it sequentially positions teeth by way of continuous gentle force.
Product codes
NXC
Device Description
The reason of this submission is that change raw material and the thickness types of TRIOCLEAR System in comparison to the primary predicate device TRIOCLEAR System (K193622).
The TRIOCLEAR System is a removable, non-sterile device intended for single patient use. TRIOCLEAR is a series of clear plastic aligners that offer a solution for patients who want an aesthetic orthodontic treatment by utilizing sets of removable aligners to correct tooth malocclusions without the use of conventional wire and bracket orthodontic technology.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
teeth
Indicated Patient Age Range
patients with permanent dentition (i.e. all second molars)
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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)
The substantial equivalence of the device is supported by non-clinical testing. The verification and validation of the device performance testing was performed and found to be acceptable and supports the claims of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Key metrics for performance testing include: Water absorption value, Solubility value, Density, Sustained clamping force, Flexural elastic modulus, Abrasive resistance, Tear resistance, Thermostability, Right-angle tear strength, Tension attenuation, Stretch elastic modulus, Yield stress, Yield stretch strain, Reducing substance, Heavy metal content, PH value, and Evaporite. All tests passed.
Predicate Device(s)
TRIOCLEAR System, K193622
Reference Device(s)
Clear Correct System, K220140
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.
0
Image /page/0/Picture/0 description: The image contains 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.
September 1, 2023
Modern Dental Laboratory (DG) Co., Ltd. % Robin Liu Compliance Manager Modern Dental Laboratory Co., Ltd. Block 1 Modern Dental Industrial Park, No.7 Nantou Songshan Lake Hi-Tech Industrial Zone Dongguan, Guangdong 523000 CHINA
Re: K231884
Trade/Device Name: TRIOCLEAR System Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: August 4. 2023 Received: August 4, 2023
Dear Robin Liu:
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.
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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 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).
Sincerelv.
Michael E. Adjodha -S
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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
Submission Number (if known)
Device Name
TRIOCLEAR System
Indications for Use (Describe)
The TRIOCLEAR System is a series of clear, lightweight, plastic appliances indicated for the treatment of tooth malocclusions in patients with permanent dentition (i.e. all second molars). Utilizing a series of increment, it sequentially positions teeth by way of continuous gentle force.
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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510(k) Summary
1. Submitter Information
| Company Name: | Modern Dental Laboratory (DG) Co., Ltd. |
|---|---|
| Company Address: | Room 102&1102&Floor 4-10,Block 1 Modern |
| Dental Industrial Park, No.7 Nantou | |
| Songshan Lake Hi-Tech Industrial Zone | |
| 523000 Dongguan,Guangdong People's | |
| Republic of China | |
| Company Phone: | T: 0769-22899211 |
| Contact Person: | Robin Liu |
| Email: | Compliance@moderndentallab.com |
| Date Prepared | May 10, 2023 |
2. Device Identification
| Device Model Name: | TRIOCLEAR System |
|---|---|
| Classification Name: | Orthodontic Plastic Bracket |
| Regulation Number: | 872.5470 |
| Product Code: | NXC |
| Class | II |
| Panel | Dental |
3. Predicated Devices
| Primary Predicate Device: | TRIOCLEAR System, K193622 |
|---|---|
| Reference Device: | Clear Correct System, K220140 |
4. Device Description
The reason of this submission is that change raw material and the thickness types of TRIOCLEAR System in comparison to the primary predicate device TRIOCLEAR System (K193622).
The TRIOCLEAR System is a removable, non-sterile device intended for single patient use. TRIOCLEAR is a series of clear plastic aligners that offer a solution for patients who want an aesthetic orthodontic treatment by utilizing sets of removable aligners to correct tooth malocclusions without the use of conventional wire and bracket orthodontic technology.
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5. Indications for Use
The TRIOCLEAR System is a series of clear, lightweight, plastic appliances indicated for the treatment of tooth malocclusions in patients with permanent dentition (i.e. all second molars). Utilizing a series of incremental tooth movement, it sequentially positions teeth by way of continuous gentle force.
6. Mechanism of Action
The mechanism of action is similar to the predicate device and supports a determination of substantial equivalence. Orthodontic tooth movement occurs through forces applied by the appliance to the dentition as each tooth follows the programmed displacement based on a dental health professional's prescription.
7. Technological Characteristics
A dental health care professional (e.g. orthodontist or dentist), prescribes the TRIOCLEAR System based on an assessment of the patient's teeth, determines a course of treatment with the system, takes physical or optical measurements of the patient's teeth and completes a prescription form. The measurements and prescription are sent to Modern DG.
Utilizing standard dental software used for tooth alignment, Modern DG designs a series of plastic trays intended to gradually realign the patient's teeth in accordance with the physician's prescription. The prescribing physician reviews and approves the model scheme before the molds are produced. Once approved, Modern DG produces the trays, which are formed of clear, thin thermoformed plastic. The trays are sent back to the dental health care professional, who then provides them to the patient, confirming fit and design. Over a period, additional trays are provided sequentially to the patient by the dental health care professional to gradually move the target teeth to the desired position.
The dental care professional monitors treatment from the moment the first aligner is delivered to when treatment is completed. The trays are held in place by pressure and can be removed by the patient at any time.
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8. Performance Testing
The substantial equivalence of the device is supported by non-clinical testing. The verification and validation of the device performance testing was performed and found to be acceptable and supports the claims of substantial equivalence.
| Items | Standards requirement | Testing results | Conclusion |
|---|---|---|---|
| Water absorption | |||
| value | ≤ 32 µ g/mm3 | 15 µ g/mm3 | Pass |
| Solubility value | ≤ 5 µg/mm3 | 0.4 µg/mm3 | Pass |
| Density | 2.6 g/cm3 | 1.18 g/cm3 | Pass |
| Sustained | |||
| clamping force | ≥ 1N | 2.14-17.96 N | Pass |
| Flexural elastic | |||
| modulus | ≥ 600 MPa | 1364.9MPa- | |
| 1535.1MPa | Pass | ||
| Abrasive | |||
| resistance | ≤0.25g/1000r | 0.0044g/1000r | |
| ~0.0074g/1000r | Pass | ||
| Tear resistance | ≥200 N/cm | 329.9N~489.4N | Pass |
| Thermostability | Mass change≤1% | 0.03% | Pass |
| Right-angle tear | |||
| strength | ≥ 100 KN/m | 217.2 KN/m | Pass |
| Tension | |||
| attenuation | ≤75% | 54.6% | Pass |
| Stretch elastic modulus | |||
| 700MPa ~ 3000MPa | 970.11MPa | Pass | |
| Yield stress≥ 25 MPa | 26.2 MPa | Pass | |
| Yield stretch strain ≥ 4% | 5.9% | Pass | |
| Stretch property | |||
| Reducing | |||
| substance | The extract was compared | ||
| with the same batch of | |||
| blank control solution of | |||
| equavolume. The difference | |||
| in consumption of 0.002 | |||
| mol/L KMnO4 solution | |||
| should not exceed 2.0 mL . | 0.15 mL | Pass | |
| Heavy metal | |||
| content | When determined by | ||
| colorimetry, the color of the | |||
| extract should not exceed | |||
| the standard control solution | ≤ 1 µ g/mL | Pass | |
| with a mass concentration | |||
| (Pb2+) = 1 μ g/mL. | |||
| PH value | The difference between the | ||
| PH value of the test solution | |||
| and the blank control | |||
| solution is not more than | |||
| 1.5. | 0.60 | Pass | |
| Evaporite | The total amount of | ||
| evaporation residue $\leq$ 2 | |||
| mg. | 0.4mg | Pass |
Some performance data got by testing as below:
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9. Biocompatibility Testing
The biocompatibility evaluation for the thermoforming sheet was conducted in accordance with the US FDA CDRH Guidance Document Number 1811 "Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process - Guidance for Industry and Food and Drug Administration Staff" as recognized by FDA.
The TRIOCLEAR System is physically stamped by thermoforming sheet without adding or removing any substance during the stamping process. Therefore, the biocompatibility of TRIOCLEAR System is substantial equivalence with thermoforming sheet.
The TRIOCLEAR System is considered mucosal membrane direct contacting for a duration of less than 30 days. The battery of testing included following tests:
- Cytotoxicity ●
- Sensitization
- Irritation
- Bacterial Reverse Mutation
- In Vitro Mammalian Cell Gene Mutation
The result of the testing met the requirements of study plan and the thermoforming sheet is considered non-cytotoxic, non-sensitizing, non-irritant, no bacterial reverse mutation, no cell gene mutation. The biocompatibility of TRIOCLEAR System is substantial equivalence with thermoforming sheet, so the TRIOCLEAR System is also considered non-cytotoxic, non-sensitizing, non-irritant, no bacterial reverse mutation, no cell gene mutation.
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10. Substantial Equivalence Comparison
The following table compares the TRIOCLEAR System to the primary predicate device TRIOCLEAR System(K193622) and reference device Clear Correct System (K220140) with respect to indications for use, technological characteristics and principles of operation, providing more detailed information regarding the basis for the determination of substantial equivalence.
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| Elements of
| Comparison | Subjective device | Primary Predicate Device | Reference Device | Explanation |
|---|---|---|---|---|
| Name | TRIOCLEAR System | TRIOCLEAR System | Clear Correct System | - |
| 510(k) Number | - | K193622 | K220140 | - |
| Manufacturer | Modern Dental Laboratory (DG) Co., | |||
| Ltd. | Perfection Aligner System Hong Kong | |||
| Limited | ClearCorrect, LLC | - | ||
| Regulation | ||||
| Number | 21 CFR 872.5470 | 21 CFR 872.5470 | 21 CFR 872.5470 | - |
| Device | ||||
| Classification | ||||
| Name | Orthodontic plastic bracket | Orthodontic plastic bracket | Orthodontic plastic bracket | - |
| Classification | ||||
| Product Code | NXC | NXC | NXC | - |
| Device Class | Class II | Class II | Class II | - |
| Indications for | ||||
| Use | The TRIOCLEAR System is a series | |||
| of clear, lightweight, plastic appliances | ||||
| indicated for the treatment of tooth | ||||
| malocclusions in patients with | ||||
| permanent dentition (i.e. all second | ||||
| molars). Utilizing a series of | ||||
| incremental tooth movement, it | ||||
| sequentially positions teeth by way of | ||||
| continuous gentle force. | The TRIOCLEAR System is a series of | |||
| clear, lightweight, plastic appliances | ||||
| indicated for the treatment of tooth | ||||
| malocclusions in patients with permanent | ||||
| dentition (i.e. all second molars). Utilizing | ||||
| a series of incremental tooth movement, it | ||||
| sequentially positions teeth by way of | ||||
| continuous gentle force. | The ClearCorrect System is indicated | |||
| for the alignment of teeth during | ||||
| orthodontic treatment of tooth | ||||
| malocclusion. | Identical | |||
| Material of | ||||
| Fabrication | Thermoplastic polyurethane-polyester | |||
| composite resin | Thermoplastic ( PET-G) | Thermoplastic polyurethane-polyester | ||
| composite resin | The subject device and the | |||
| reference device have the | ||||
| same general type of | ||||
| material of fabrication. | ||||
| Material | ||||
| Properties | Demonstrates a high level of chemical | |||
| resistance, abrasive resistance, tear | ||||
| resistance, Strength, elasticity, | ||||
| transparency, plasticity, excellent | ||||
| formability and stability for use as | ||||
| thermoforming sheet. | Demonstrates sufficient tensile strength, | |||
| ductility, chemical resistance, and clarity | ||||
| for use as a clear tray aligner. | Demonstrates a high level of chemical | |||
| resistance, abrasive resistance, tear | ||||
| resistance, Strength, elasticity, | ||||
| transparency, plasticity, excellent | ||||
| formability and stability for use as | ||||
| thermoforming sheet. | Identical | |||
| Design | Image: clear aligners | Image: clear aligner | Image: clear aligner | Identical |
| Appearance and shape is | ||||
| similar. | ||||
| Mode of Action | Orthodontic tooth movement occurs | |||
| through forces applied by the | ||||
| appliance to the dentition as each | ||||
| tooth follows the programmed | ||||
| displacement based on doctor's | ||||
| prescription. | ||||
| Two steps aligners will be worn by | ||||
| patient for each set. | Orthodontic tooth movement occurs | |||
| through forces applied by the appliance to | ||||
| the dentition as each tooth follows the | ||||
| programmed displacement based on | ||||
| doctor's prescription. | ||||
| Three steps aligners will be worn by | ||||
| patient for each set. | The aligner is an orthodontic appliance | |||
| intended for intra-oral use. Individual | ||||
| devices will be used between 20 – 22 | ||||
| hours per day for a period ranging | ||||
| from one to three weeks The corrective | ||||
| forces to align teeth are primarily | ||||
| generated by the difference between | ||||
| the starting tooth position and the | ||||
| planned tooth position defined by | ||||
| the tray. Features can be added to the | ||||
| aligner that engage with composite | ||||
| resin tooth attachments to improve | ||||
| aligner retention and/or to apply force | ||||
| in directions that cannot be achieved by | Equivalence | |||
| The mode of operation of | ||||
| the Subject Device is | ||||
| identical to the Primary | ||||
| Predicate Device and is | ||||
| largely equivalence to the | ||||
| Reference Device. | ||||
| engaging with tooth surfaces alone. | ||||
| Treatment time | Each aligner should be worn for at least (20) hours per day. Each aligner should be changed every 7 days. Each step's changing time may change at the doctor's discretion, subjected to good compliance and fit as the patient progresses | Each aligner should be worn for at least (20) hours per day. Each aligner should be changed every 3-9 days. Each step's changing time may change at the doctor's discretion, subjected to good compliance and fit as the patient progresses. | Individual devices will be used between 20 – 22 hours per day for a period ranging from one to three weeks. | Equivalence The treatment is approved by a dentist, worn for an average of 20 hours a day, and requires regular checking |
| Technological Characteristics | Treatment of tooth malocclusion is via a series of plastic appliances that incrementally moves teeth to a desired end-state. | Treatment of tooth malocclusion is via a series of plastic appliances that incrementally moves teeth to a desired end-state. | The corrective forces to align teeth are primarily generated by the difference between the starting tooth position and the planned tooth position defined by the tray. | Equivalence The mode of operation of the Subject Device is identical to the Primary Predicate Device and is largely equivalence to the Reference Device |
| OTC or Rx | Rx | Rx | Rx | Identical |
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11. Substantial Equivalence Conclusion
Based on the above comparison between subjective device and primary predicate device, Reference Device demonstrates that the subjective device TRIOCLEAR System is as safe, as effective, and is substantially equivalent to the Primary predicate devices (K193622) and the Reference Device (K220140).