Nightwear Aligners

K221537 · Smylio, Inc. · NXC · Apr 5, 2023 · Dental

Device Facts

• Record ID: K221537
• Device Name: Nightwear Aligners
• Applicant: Smylio, Inc.
• Product Code: NXC · Dental
• Decision Date: Apr 5, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5470
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Nightwear Aligners are indicated for the alignment of permanent teeth during orthodontic treatment of malocclusion.

Device Story

Nightwear Aligners are thermoformed, patient-specific, transparent polyurethane plastic trays used for orthodontic tooth movement. Input consists of digital dental scans provided by a dental professional. A treatment plan is generated and approved by the clinician, resulting in a sequence of 3D-printed models used to thermoform the aligners. The device is worn by the patient for 9-12 hours daily, removed for eating and cleaning. Aligners apply gentle, continuous force to teeth to achieve incremental movement toward a final position. Clinicians monitor treatment progress from the first to the final aligner. The device benefits patients by providing a removable, aesthetic orthodontic treatment option for malocclusion.

Clinical Evidence

Clinical study conducted on 20 patients under IDE G200298. Results demonstrated that tooth alignment occurs with 9-12 hours of daily wear for one week per aligner stage in patients with mild malocclusions as determined by a treating dentist.

Technological Characteristics

Thermoformed transparent polyurethane plastic aligners. Patient-specific dimensions. Biocompatibility per ISO 10993-1, -5, -10, -11. Material testing per ASTM D638 (tensile) and ASTM D790 (flexural). Manufacturing involves 3D printing of models followed by thermoforming.

Indications for Use

Indicated for alignment of permanent teeth during orthodontic treatment of malocclusion in patients requiring mild malocclusion correction.

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

• iSMILE Aligners (K200908)

Reference Devices

• Smylio Invisible Clear Aligners (K212660)
• Smylio Invisible Clear Aligners (K172784)

Submission Summary (Full Text)

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April 5, 2023

Smylio Inc. % Jennifer Day Regulatory Affairs Consultant Prime Path Medtech 1321 Upland Dr. Suite 6792 Houston, Texas 77043

Re: K221537

Trade/Device Name: Nightwear Aligners Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: May 26, 2022 Received: May 27, 2022

Dear Jennifer Day:

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 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).

Sincerely.

# 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

510(k) Number (if known) K221537

Device Name Nightwear Aligners

Indications for Use (Describe)

Nightwear Aligners are indicated for the alignment of permanent teeth during 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)

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# Attachment A: 510(k) Summary

### 510(k) SUMMARY

A summary of 510(k) safety and effectiveness information for this submission in accordance with the requirements of 21 CFR 807.92.

| Submitter: | Smylio Inc.<br>48890 Milmont Dr<br>Suite 101D<br>Fremont CA, 94538 |
|---------------------------|----------------------------------------------------------------------------------------|
| Company Contact Person: | Ren Menon, CEO |
| Phone: | 510-868-2184 |
| Email: | [e-mail] |
| Submission Correspondent: | Jennifer Day, Regulatory Affairs Consultant<br>Breanne Butler, PhD |
| Company: | Prime Path Medtech Inc. |
| Address: | 1321 Upland Dr, Ste 6792 Houston, TX 77043 |
| Phone: | 860-810-5594 |
| Email: | [e-mail] |
| Date Prepared: | May 26, 2022 |
| Proprietary Name: | Smylio Nightwear Aligners |
| Common Name: | Orthodontic plastic bracket. |
| Product Code: | NXC – Orthodontic plastic bracket. |
| Device Classification: | Class II, 21 CFR 872.5470 |
| Primary Predicate Device: | iSMILE Aligners (K200908) |
| Reference Predicates: | Smylio Invisible Clear Aligners (K212660)<br>Smylio Invisible Clear Aligners (K172784) |

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#### Device Description:

The Smylio Nightwear Aligners are thermoformed plastic aligners designed to be worn in sequence to facilitate the movement to the final desired position. The sequential aligners introduce incremental movements that move teeth by way of gentle continuous force. The aligners are to be worn at least 9 to 12 hours a day and are to be removed for eating and for cleaning.

Smylio Nightwear Aligners are designed from digital scans of a patient's dentition submitted by a dental health professional (e.g., dentist or orthodontist). Using the scan, sequential dental models are designed and approved by the treating physician prior to manufacturing.

Once the treatment plan is reviewed and approved by a dental health professional, each 3D model from the treatment plan is manufactured. The aligner trays are then manufactured by thermoforming a dental thermoplastic sheet over each model. The aligners are shipped to the treating clinician's office where they are then distributed to the patient in sequential stages. The patients' dental health professional then monitors their treatment of the first aligner to the delivery of the final aligner.

#### Indications for Use:

Nightwear Aligners are indicated for the alignment of permanent teeth during orthodontic treatment of malocclusion.

#### Comparison to Predicate Devices:

Smylio Nightwear Aligners are functionally equivalent to the following predicate device: iSMILE Aligners (K200908). The following table demonstrates the functional specifications of Smylio Nightwear Aligners are substantially equivalent to the predicate devices.

| Specification | Subject Device: Smylio<br>Nightwear Aligners | Predicate Device: iSMILE<br>Aligners (K200908) | Comparison<br>Result |
|------------------------|----------------------------------------------|------------------------------------------------|----------------------|
| Regulation<br>Number | 21 CFR 872.5470 | 21 CFR 872.5470 | Same |
| Classification<br>Name | Orthodontic Plastic Bracket | Orthodontic Plastic Bracket | Same |
| Product Code | NXC | NXC | Same |
| Classification | Class II | Class II | Same |

Table 1. Predicate Device Comparison Table

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| Specification | Subject Device: Smylio<br>Nightwear Aligners | Predicate Device: iSMILE<br>Aligners (K200908) | Comparison<br>Result |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| OTC or Rx | Rx | Rx | Same |
| Material | Thermoplastic Polymer | Thermoplastic Polymer | Same |
| Material<br>Properties | Demonstrates sufficient<br>tensile strength, elasticity,<br>ductility, chemical resistance,<br>and clarity for use as a clear<br>tray aligner. | Demonstrates sufficient<br>tensile strength, elasticity,<br>ductility, chemical resistance,<br>and clarity for use as a clear<br>tray aligner. | Same |
| Biocompatible | Yes | Yes | Same |
| Specification | Subject Device: Smylio<br>Nightwear Aligners | Predicate Device: iSMILE<br>Aligners (K200908) | Comparison<br>Result |
| Device<br>Description | Nightwear Aligners are a<br>sequence of transparent<br>aligners created from a<br>digital orthodontic treatment<br>plan. The Nightwear Aligners<br>are fabricated of a<br>transparent thermoformed<br>polyurethane plastic. Each<br>aligner delivers a unique<br>combination of minor forces<br>to create the planned tooth<br>movement. The digital<br>orthodontic treatment plan<br>is created by a dental health<br>professional.<br>The Nightwear Aligners<br>incorporate the use of<br>attachments to create spaces<br>and force points in order to<br>cause minor tooth<br>movement. These force<br>points are located in specific<br>areas and positioned in such<br>a way that they provide a<br>continuous force which<br>slowly dissipates over time<br>on the tooth to be moved for<br>as long as the aligner is worn. | The iSMILE is a sequence of<br>transparent aligners created<br>from a digital orthodontic<br>treatment plan. The iSMILE<br>aligner is fabricated of a<br>transparent thermoformed<br>polyurethane plastic. Each<br>aligner delivers a unique<br>combination of minor forces<br>to create the planned tooth<br>movement. The digital<br>orthodontic treatment plan<br>is created by a dental health<br>professional.<br>The iSMILE Aligner<br>incorporates the use of<br>attachments to create spaces<br>and force points in order to<br>cause minor tooth<br>movement. These force<br>points are located in specific<br>areas and positioned in such<br>a way that they provide a<br>continuous force which<br>slowly dissipates over time<br>on the tooth to be moved for<br>as long as the aligner is worn. | Same |
| Anatomy<br>Location | Mouth; mucosal | Mouth; mucosal | Same |
| Size | Patient Specific | Patient Specific | Same |
| Specification | Subject Device: Smylio<br>Nightwear Aligners | Predicate Device: iSMILE<br>Aligners (K200908) | Comparison<br>Result |
| Manufacturing<br>Method | Thermoforming | Thermoforming | Same |
| Patient<br>Removable? | Yes | Yes | Same |
| Indication for<br>Use | Nightwear Aligners are<br>indicated for the alignment<br>of permanent teeth during<br>orthodontic treatment of<br>malocclusion. | iSMILE is indicated for the<br>alignment of teeth during<br>orthodontic treatment of<br>malocclusion. | Same |
| Mode of<br>Action | Orthodontic tooth<br>movement occurs through<br>forces applied by the<br>appliance to the dentition as<br>each tooth follows the<br>programmed displacement<br>based on a doctor's<br>prescription | Orthodontic tooth<br>movement occurs through<br>forces applied by the<br>appliance to the dentition as<br>each tooth follows the<br>programmed displacement<br>based on a doctor's<br>prescription | Same |

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#### Comparison of Indications for Use to Predicate Devices:

The indications for use of the Smylio Nightwear Aligners are the iSMILE Aligners (K200908) as they are both indicated for use in the alignment of permanent teeth through orthodontic treatment of misalignment and malocclusion. The aligners guide teeth to their final position by way of continuous gentle forces. Thus, the Smylio Nightwear Aligners can be considered substantially equivalent to its predicate device.

#### Comparison of Technological Characteristics to Predicate Devices:

Based on the above comparison, the design, construction, and performance characteristics of the Smylio Nightwear Aligners is similar to that of the iSMILE Aligners (K200908). Thus, the Smylio Nightwear Aligners can be considered substantially equivalent to its predicate device.

#### Non-clinical performance testing:

The use of thermoplastic materials for sequential aligners intended to treat malocclusions has been well documented in scientific literature regarding incremental tooth moving forces.

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However, durability testing was conducted on the Smylio Nightwear Aligners Real world use was simulated to ensure that the aligner material and manufacturing process produced aligners that were suitable for their prescribed period of use.

Material property testing was performed to investigate elongation, tensile and flexural properties of the material in accordance with ASTM D638 and ASTM D790.

An internal manufacturing validation was performed to test the manufacturing process for Smylio Nightwear Aligners. The robustness of the process was demonstrated from 3D printing through thermoforming.

The thermoplastic material used for Smylio Nightwear Aligners is broadly used in many aligners. Biocompatibility testing for the aligner material, the only patient contacting material, was in accordance with the International Standard "Biological evaluation of medical devices" ISO 10993-1, ISO 10993-5:2009, ISO 10993-10:2010, ISO 10993-10:2010, and ISO 10993-11:2017.

#### Clinical performance testing:

Clinical performance testing was conducted on 20 patients for the Smylio Nightwear Aligners under an FDA cleared IDE application (G200298). The study results demonstrated that tooth alignment may occur for patients with at least 9 to 12 hours of wear time per day for one week prior to moving to the next aligner for patients with mild malocclusions as determined by the treating dentist.

#### Conclusion:

Based on similarities in indications for use, technological characteristics, non-clinical performance testing, and clinical performance testing, Smylio Nightwear Aligners are substantially equivalent to the iSMILE Aligners (K200908).