(558 days)
eCligner®, K143499
No
The summary describes a physical device (clear aligners) and the manufacturing process, with no mention of AI/ML in the intended use, device description, or performance studies.
Yes
The device is indicated for the treatment of tooth malocclusions, which is a therapeutic purpose.
No
The device is an orthodontic appliance used for the treatment of tooth malocclusions, not for diagnosing medical conditions.
No
The device description explicitly states it is a "series of clear plastic aligners," which are physical, removable devices. The performance studies also focus on the physical properties and validation of these physical aligners. There is no mention of software being the primary or sole component of the device.
Based on the provided information, the TRIOCLEAR System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- The TRIOCLEAR System is a physical device (clear plastic aligners) used to mechanically move teeth to correct malocclusions.
- Its function is based on applying force to the teeth, not on analyzing biological samples.
- The "Intended Use" clearly states it's for the "treatment of tooth malocclusions," which is a mechanical/physical intervention, not a diagnostic process involving biological samples.
Therefore, the TRIOCLEAR System falls under the category of a medical device used for treatment, not an IVD device used for diagnosis.
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 incremental tooth movement, it sequentially positions teeth by way of continuous gentle force.
Product codes
NXC
Device Description
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/Dentition
Indicated Patient Age Range
Patients with permanent dentition (i.e. all second molars).
Intended User / Care Setting
A dental health care professional (e.g. orthodontist or dentist) prescribes the TRIOCLEAR System. The trays are sent back to the dental health care professional, who then provides them to the patient, confirming fit and design. The dental care professional monitors treatment.
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)
Physical properties testing was conducted on the device. Tensile properties (tensile strength, modulus and elongation) were tested according to ISO 527-2. Hardness was tested according to ASTM D785. Humidity absorption was tested by immersion of specimen in distilled water during 24 hours at 23°C. All results of the above tests met the acceptance criteria.
The substantial equivalence of the device is supported by non-clinical testing. Validation was performed on the digital and 3D printed models, as well as the thermoformed aligners and the differences were calculated using a CAD overlay method and by using RMS calculations. All aligners fabricated met the pre-defined acceptance criteria and received an A grade for form and fit of the thermoformed aligners.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
3MTM Clear Tray Aligner, K163689
Reference Device(s)
eCligner®, K143499
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
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July 06, 2021
Perfection Aligner System Hong Kong Limited Alwin Ngai Director Flat/Rm 4B, 4/F, Hang Fat Industrial Building, 550-556 Castle Peak Road Kowloon, HONG KONG
Re: K193622
Trade/Device Name: TRIOCLEAR System Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: May 10, 2021 Received: June 2, 2021
Dear Alwin Ngai:
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,
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
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Indications for Use
510(k) Number (if known) K193622
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 incremental tooth movement, 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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K193622
Section 5: 510(k) Summary
1. Submitter Information
| Company Name: | Perfection Aligner System Hong Kong Limited |
|---|---|
| Company Address: | Flat/Rm 4B, 4/F, Hang Fat Industrial Building |
| 550-556 Castle Peak Road, Kowloon, Hong Kong | |
| Company Phone: | (852) 3766 0737 |
| Company Fax: | (852) 2577 7511 |
| Contact Person: | Mr. Alwin Ngai |
| Email: | alwin.ngai@moderndentalgp.com |
| Date Prepared | June 29, 2021 |
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: | 3MTM Clear Tray Aligner, K163689 |
|---|---|
| Reference Device: | eCligner®, K143499 |
4. Device Description
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.
5. Indications for Use
The TRIOCLEAR System is a series of clear, lightweight, plastic appliances
510(k) Files: Section 5
Page 1 of 7
4
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 devices 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 from. The measurements and prescription are sent to Perfection.
Utilizing standard dental software used for tooth alignment. Perfection 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, Perfection 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.
This technology is essentially identical to that used by a number of sequential alignment systems, including the predicated referenced below.
8. Performance Testing
510(k) Files: Section 5
5
Physical properties testing was conducted on the device. Tensile properties (tensile strength, modulus and elongation) were tested according to ISO 527-2. Hardness was tested according to ASTM D785. Humidity absorption was tested by immersion of specimen in distilled water during 24 hours at 23°C. All results of the above tests met the acceptance criteria.
The substantial equivalence of the device is supported by non-clinical testing. Validation was performed on the digital and 3D printed models, as well as the thermoformed aligners and the differences were calculated using a CAD overlay method and by using RMS calculations. All aligners fabricated met the pre-defined acceptance criteria and received an A grade for form and fit of the thermoformed aligners.
9. Biocompatibility Testing
The biocompatibility evaluation for the final finished device 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 considered mucosal membrane direct contacting for a duration of greater than 30 days. The battery of testing included following tests:
- Cytotoxicity ●
- Sensitization ●
- Irritation
- Acute Systemic Toxicity
- Pyrogenicity
- Subacute Toxicity
- Implantation
The result of the testing met the requirements of study plan and the TRIOCLEAR System is considered non-cytotoxic, non-sensitizing, nonirritant, no acute systemic toxicity, non-pyrogenic, no subacute repeated exposure systemic toxicity, and nonirritant when compared to implanted negative control article.
10. Substantial Equivalence Comparison
510(k) Files: Section 5
6
The following table compares the TRIOCLEAR System to the predicate devices 3M™ Clear Tray Aligner and eCligner® 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 | Subject Device | Primary Predicate Device | Reference Device |
|---|---|---|---|
| Name | TRIOCLEAR System | 3M™ Clear Tray Aligner | eCligner® |
| 510(k) Number | K193622 | K163689 | K143499 |
| Manufacturer | Perfection Aligner System Hong Kong | ||
| Limited | 3M Unitek Corporation | eClear International Co., Ltd. | |
| 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. | 3M™ Clear Tray Aligner 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. | eCligner® is a series of clear, lightweight, | ||
| plastic appliances indicated for the | |||
| correction of dental malocclusion in | |||
| patients with permanent dentition (i.e. all | |||
| second molars). The eCligner® System is | |||
| intended for minor anterior tooth | |||
| movement by way of continuous gentle | |||
| force. | |||
| Material of | |||
| Fabrication | Thermoplastic | Thermoplastic | Thermoplastic |
| Material | |||
| Properties | Demonstrates sufficient tensile strength, | ||
| ductility, chemical resistance, and clarity for | |||
| sue as a clear tray aligner. | Demonstrates sufficient tensile strength, | ||
| ductility, chemical resistance, and clarity for | |||
| sue as a clear tray aligner. | Demonstrates sufficient tensile strength, | ||
| ductility, chemical resistance, and clarity | |||
| for sue as a clear tray aligner. | |||
| Design | Image: Clear aligners arranged in a loose S shape | Image: Clear aligners arranged in a loose S shape | Image: Clear aligner for the lower teeth |
| 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. | |||
| Three 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. | |||
| One single aligner 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. | |||
| 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. | Treatment of tooth malocclusion is via a | ||
| series of plastic appliances that | |||
| incrementally moves teeth to a desired | |||
| end-state. | |||
| OTC or Rx | Rx | Rx | Rx |
510(k) Files: Section 5
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9
11. Substantial Equivalence Conclusion
Based on the indications for use and performance information provided in this submission, demonstrates that the TRIOCLEAR System is as safe, as effective, and is substantially equivalent to the predicate devices.