Serafin®

K232074 · Tns Co., Ltd. · NXC · Feb 22, 2024 · Dental

Device Facts

• Record ID: K232074
• Device Name: Serafin®
• Applicant: Tns Co., Ltd.
• Product Code: NXC · Dental
• Decision Date: Feb 22, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5470
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

The Serafin is intended for the orthodontic treatment of malocclusion

Device Story

Serafin is a clear aligner system consisting of transparent, removable orthodontic appliances. Input consists of a 3D digital scan of the patient's teeth. Software generates a 3D model, incrementally modifying tooth positions to create a treatment plan, which is reviewed and approved by a dental practitioner. The approved model is 3D printed, and thermoplastic polyurethane (Zendura FLX) is thermoformed over the model, trimmed, and marked. The device is used in a dental clinic setting under the direction of a dental practitioner. The patient wears the aligners for at least 20 hours per day for 6 to 24 months. The aligners apply continuous, gentle force to realign teeth in small increments. This treatment benefits patients by correcting malocclusions such as overbite, underbite, crossbite, gap teeth, open bite, and crowding.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993-1, 5, 10, 11, 17, 18, 23, ISO 7405, and ADA ANSI 41-2020. Physical/chemical testing performed per ISO 20795-2, including flexural strength, water sorption, and solubility. All test results met preset criteria.

Technological Characteristics

Clear aligner system made of Zendura FLX (thermoplastic polyurethane/copolyester). 3-layer structure. Thermoforming manufacturing process. Surface device, permanent contact (>30 days) with mucosal membrane. Software-driven 3D modeling and 3D printing of dental models. Complies with ISO 20795-2 and ISO 10993 series.

Indications for Use

Indicated for orthodontic treatment of malocclusion in children (with full permanent dentition) and adults. Contraindicated for severe cases requiring large tooth movements, such as rotations over 20 degrees, large gaps, or teeth requiring intrusion or extrusion.

Regulatory Classification

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.

Predicate Devices

• Invisalign (K220287)

Submission Summary (Full Text)

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February 22, 2024

TNS Co., Ltd. Won-Gun Chang CEO 908, 46, Digital-ro 9gil Geumcheon-gu. Seoul 08512 SOUTH KOREA

Re: K232074

Trade/Device Name: Serafin® Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: November 23, 2023 Received: November 24, 2023

Dear Won-Gun Chang:

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 (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 available 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 ([e-mail]) or phone [phone] or 301-796-7100).

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Sincerely,

# Michael E. Adjodha -S

Michael E. Adjodha, MChE, RAC, CQIA 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known) K232074

Device Name Serafin®

Indications for Use (Describe) The Serafin is intended for the orthodontic treatment of 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) 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

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#### 006_ 510(k) SUMMARY

Date: February 21, 2024

#### 1. SUBMITTER

TNS Co., Ltd. 908, 46, Digital-ro 9gil, Geumcheon-gu, Seoul, Republic of Korea TEL : [phone] FAX : [phone] Contact Name: Won-gun Chang Email: [e-mail]

#### 2. DEVICE

Serafin® ·Trade Name: ·Common Name: Clear Aligner System · Regulation Number 872.5470 ·Class: 2 ·Classification Product Code: NXC ·Classification Name: Orthodontic plastic bracket

# 3. PREDICATE DEVICE

Serafin®

: K220287 (Primary predicate) Invisalign, Invisalign, Align Technology Inc.

# 4. DEVICE DESCRIPTION

Serafin® is composed of series of transparent removable orthodontic appliances manufactured using thermoforming technology based on a 3D model of the patient's teeth, customized according to a Dental Practitioner's specific prescription, indicated for treatment of dental malocclusion by applying continuous gentle force to realign teeth.

The time for each stage of aligner usage is set in the personal treatment plan, and this varies for each patient and the Dental Practitioner's choice. Each set of aligners needs to be worn for at least 2 weeks. Patients the total treatment time lasts about 6 to 24 months.

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# 5. INDICATIONS FOR USE

Serafin®

- The Serafin is intended for the orthodontic treatment of malocclusion.
### 6. NON-CLINICAL TESTING

The following test articles were tested based on the referenced standard. All the test results met the preset test criteria.

1) Physical and chemical test

- Guideline on Review and Approval for appliance, Orthodontic, Resin (Sheet Type)(2018.12.) (MFDS)
- Appearance, Dimension, Water sorption & solubility, 3-point flexural strength, hardness

- Appearance, pH, Potassium permanganate reducing substances residue, Residue on evaporation, Heavy metals, Ultraviolet-visible spectrum

- ISO 20795-2 Dentistry Base polymers Part 2: Orthodontic base polymers
#### 2) Biological evaluation

- ISO 10993-1 Biological evaluation of medical devices Part 1: Evaluation . and testing within a risk management process
- . ISO 7405 – Dentistry - Evaluation of biocompatibility of medical devices used in dentistry
- . ISO 10993-17 - Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances
- ISO 10993-18 – Biological evaluation of medical devices - Part 18: Chemical characterization
- . ISO 10993-5 - Biological evaluation of medical devices - Part 5: Cytotoxicity
- . ISO 10993-10 - Biological evaluation of medical devices - Part 10: Skin sensitization, Acute oral mucosa irritation, Intracutaneous reactivity
- ISO 10993-11 - Biological evaluation of medical devices - Part 11: Acute systemic toxicity
- ISO 10993-23 Biological evaluation of medical devices Part 23: Tests for

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irritation

- ADA ANSI 41-2020 Evaluation of Biocompatibility of Medical Devices Used • in Dentistry
# 7. SUBSTANITAL EQUIVALENCE

| | Subject device | Predicate Device | Discuss/Justify the<br>Differences |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|
| 510(k) Number | K232074 | K220287 | - |
| Trade Name | Serafin® | Invisalign | - |
| Manufacturer | TNS Co., Ltd. | Align Technology Inc. | - |
| Common Name | Clear Aligner System | Aligner, Sequential | Same |
| Device Class | 2 | 2 | Same |
| Product Code | NXC | NXC | Same |
| Device Description | Serafin® is composed of series of transparent removable orthodontic appliances manufactured using thermoforming technology based on a 3D model of the patient's teeth, customized according to a Dental Practitioner's prescription, indicated for treatment of dental malocclusion by applying continuous gentle force to realign teeth. The time for each stage of aligner usage is set in the personal treatment plan, and this varies for each patient and the Dental Practitioner's choice. Each set of aligners needs to be | Invisalign is series of transparent removable orthodontic appliance, indicated for treatment of dental malocclusion. Invisalign consists of an upper and lower parts in variable sizes and lengths customized for a specific patient. It is produced by using 3D printer based on 3D scanned image file sent by a Dental Practitioner. The aligners and attachment templates are made of thermoplastic polymer, with/without PFA system made of photopolymerizable methacrylate based resin. | Equivalent |
| | | | |
| | worn for at least 2 weeks.<br>Patients the total treatment time<br>lasts about 6 to 24 months. | | |
| Indications for use | The Serafin is intended for the<br>orthodontic treatment of<br>malocclusion. | The Invisalign System is<br>intended for the orthodontic<br>treatment of malocclusion. | Same |
| Clinical condition | Overbite, underbite, crossbite,<br>gap teeth, open bite, crowded<br>teeth, baby and permanent<br>teeth.<br>Limitations include severe<br>cases where large movement of<br>a tooth is necessary such as a<br>tooth rotated over 20 degrees,<br>large gap between teeth, teeth<br>which require intrusion or<br>extrusion | Overbite, underbite, crossbite,<br>gap teeth, open bite, crowded<br>teeth, baby and permanent<br>teeth.<br>Limitations include severe<br>cases where large movement of<br>a tooth is necessary such as a<br>tooth rotated over 20 degrees,<br>large gap between teeth, teeth<br>which require intrusion or<br>extrusion | Same |
| Patient Population | Child and adolescent(when<br>full permanent dentition is<br>present), Adults | Children, Adolescents and<br>Adults | Same |
| Use Location | Dental intraoral Devices | Dental intraoral Devices | Same |
| OTC or<br>Prescription (Rx)<br>Device | Rx only | Rx only | Same |
| Design | | | |
| Principle of<br>Operation | Serafin® is series of transparent<br>removable orthodontic<br>appliances, indicated for<br>treatment of dental<br>malocclusion. It is produced by<br>using 3D printer based on 3D<br>scanned image file sent by a<br>Dental Practitioner along with a<br>prescription of a specific<br>patient. Series of clear plastic<br>appliances (Aligners) moves | The Invisalign System consists<br>of a series of doctor-prescribed,<br>thin, clear plastic removable<br>orthodontic appliances<br>(aligners) and proprietary 3-D<br>software. The aligners gently<br>move the<br>patient's teeth in small<br>increments from their original<br>state to a more optimal, treated<br>state. | Equivalent |
| | | | |
| Appearance | the patients' teeth in small<br>increments from their original<br>state to a final, treated state by<br>applying continuous gentle<br>force to teeth while the patient<br>is wearing it. | Image: Upper and lower parts | Equivalent |
| | | Image: Orthodontic aligners | |
| 3D Software | 3D Software: Produces 3D<br>model file of the the digital<br>scan.<br>Create a treatment plan which is<br>reviewed by dental practitioner<br>to reject or request<br>modifications.<br>Approved treatment plan model<br>is 3D printed. | 3D Software: Produces 3D<br>model file of the PVS<br>impression or the digital scan.<br>Create a treatment plan which is<br>reviewed by dental practitioner<br>to reject or request<br>modifications.<br>Approved treatment plan model<br>is 3D printed. | Equivalent |
| Materials | Thermoplastic polymer :<br>Zendura FLX :<br>Thermoplastic<br>Urethane,<br>Copolyester | Thermoplastic polymer<br>SmartTrack™ | Equivalent |
| | (3-layer structure) | (Multilayer structure) | |
| Physical State | Transparent removable<br>orthodontic appliances consist<br>of an upper and lower parts | Transparent removable<br>orthodontic appliances consist<br>of an upper and lower parts | Same |
| Material property | Zendura FLX Demonstrates<br>sufficient Ultimate Flexural<br>Strength, Water Sorption,<br>Water Solubility as per ISO<br>20795-2 : 2013 | SmartTrack™ is material<br>engineered for use with<br>Invisalign orthodontic | Equivalent |
| | | | |
| | | treatment<br>(Polyurethane) | |
| | | Intended to be used as dental<br>aligner | |
| | Intended, marketed to be used<br>as dental aligner | | |
| Manufacturing<br>process | Thermoforming on models,<br>Trimming, Marking | Thermoforming on models,<br>Trimming, Marking | Same |
| Biological | | | |
| Tissue Contact | Surface device, permanent use<br>(>30 days), Mucosal membrane | Surface device, permanent use<br>(>30 days), Mucosal membrane | Same |
| Anatomical site | Intact teeth, gingival mucosa,<br>interior vermilion (inner lip),<br>and tongue | Intact teeth, gingival mucosa,<br>interior vermilion (inner lip),<br>and tongue | Same |
| Contact duration | at least 20 hrs or longer a day,<br>up to 30 days | at least 20 hrs or longer a day,<br>up to 30 days | Same |
| Biocompatiblility | Biological risk assessment,<br>Toxicological risk assessment<br>as per ISO 10993-1, ISO 7405 | Biocompatibility per the ISO<br>10993 series standards | Equivalent |

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# 8. SUBSTANTIAL EQUIVALENCE DISCUSSION

The subject devices share the same indications for use and the principle of operation as the predicate devices. They are intended for the same clinical conditions, patient populations, and use locations.

Predicate device includes an optional mandibular advancement feature (MAF), but subject device does not provide a MAF feature. The MAF option is a necessary function for 'Skeletal malocclusion', so it does not correspond to the indications for subject device.

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Both devices comprise a series of transparent, removable orthodontic appliances, used for at least 20 hours a day over a period of several weeks. The manufacturing process begins with a 3D image file of a patient's dentition, which serves as an input to each manufacturer's software. Each software identifies the individual teeth requiring treatment. The software then generates a 3D model of the patient's dentition, incrementally modifying it towards alignment. This 3D model is then printed out using a 3D printer. Subsequently, a thermoplastic polyurethane material is heated and moulded onto the 3D printed model, known as a thermoforming process. Any excess material is eliminated by trimming process. The resulting plastic appliances, both for Serafin® and Invisalign, are designed to apply a gentle, continuous force on the malocclusion site to realign the teeth.

Correspondingly, the principles of operation, intended use, manufacturing process, and 3D modeling process for Serafin® and Invisalign are identical. Both devices utilize a similar thermoforming polymer as a material, which demonstrates chemical, biological, and functional equivalence. The materials are thermoplastic polymers with a biocompatible polyurethane copolymer and are intended for use as clear aligner material.

However, since the materials are not exactly the same, further biological assessments and pre-clinical performance tests have been carried. For biocompatibility, Serafin® was tested as per ISO 10993-1 in Biological Risk Assessment. In addition, Toxicological Risk Assessment was conducted to monitor and mitigate the biological risk from unintended process residuals and degradation material under the light-curing process in 3D printing and the thermoforming process.

Regarding physical properties and clinical performance, Zendura FLX was tested according to "ISO 20795-2 Dentistry - Base polymers - Part 2: Orthodontic base polymers," under a 37°C wet environment. Since orthodontic base polymers are categorized as Type 3 (thermoplastic materials), testing was conducted for Flexural Modulus, Flexural Strength, Tear Strength, Water Sorption, and Water Solubility. The Flexural Modulus did not meet standard requirement of 1500 MPa. However, this requirement is relevant to highly rigid or inflexible materials, which does not reflect the

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current requirements for thermoplastic aligners. Considering that Serafin® and Invisalign are engineered to apply a subtle force for realignment, this standard does not apply, and the value primarily serves as an informative detail about the device's physical properties. The other results conformed to the standard, indicating good toughness, an effective ability to move teeth, low water uptake, and low water solubility.

Consequently, it can be concluded that the subject devices are substantially equivalent to the predicate devices in terms of similarity, risk acceptability, and efficacy.