Smylic Invisible Clear Aligners

K173784 · Smylio, Inc. · NXC · Aug 23, 2018 · Dental

Device Facts

• Record ID: K173784
• Device Name: Smylic Invisible Clear Aligners
• Applicant: Smylio, Inc.
• Product Code: NXC · Dental
• Decision Date: Aug 23, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5470
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Smylio Invisible Clear Aligners is indicated for use in the alignment of permanent teeth through orthodontic treatment of misalignment and malocclusion.

Device Story

Smylio Invisible Clear Aligners are intraoral thermoformed plastic aligners used for orthodontic tooth movement. Process: 1) Capture patient dentition via oral scan or physical impression; 2) Import data into 3Shape CAD/CAM software for treatment planning and sequential model generation; 3) 3D print molds based on treatment plan; 4) Thermoform plastic sheets (Zendura) over molds. Aligners are worn 20-22 hours/day, removed for eating/cleaning. Used in clinical settings under physician supervision. Output is a series of sequential aligners providing continuous gentle force to move teeth to desired positions. Benefits include correction of malocclusion and misalignment.

Clinical Evidence

No clinical data. Bench testing only. Manufacturing validation assessed dimensional accuracy of digital models, 3D printed molds, and thermoformed aligners using 3rd party software and digital calipers. All translational measurements were within 0.3 mm and rotational measurements within 3° of target values. Biocompatibility testing performed per ISO 7405:2008.

Technological Characteristics

Intraoral thermoformed plastic aligners. Materials: Co-polyester or Co-polymer (Zendura). Manufacturing: CAD/CAM software (3Shape), 3D printing of molds, thermoforming. Biocompatibility: ISO 7405:2008. Connectivity: Digital data import for treatment planning.

Indications for Use

Indicated for alignment of permanent teeth in patients with misalignment and malocclusion. Prescription use only.

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

• Derby Dental Laboratory Custom Clear Aligner System (K173785)

Reference Devices

• 3Shape OrthoSystem™ Software (K152086)
• ClearCorrect System (K113618)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 23, 2018

Smylio, Inc % Mr. Bill Jacqmein Regulatory Affairs Consultant JCQ Consulting 11218 Zest Court NE Blaine, Minnesota 55449

Re: K173784

Trade/Device Name: Smylio Invisible Clear Aligners Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: June 7, 2018 Received: June 12, 2018

Dear Bill Jacqmein:

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

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# 510(k) SUMMARY K173784

| Submitter: | | 48890 Milmont Drive<br>Fremont, CA 94538 |
|------------------------------|------------------|-------------------------------------------------------------------------------------|
| Company Contact<br>Person: | | Renjith S Menon, CEO |
| | Phone:<br>Email: | [phone]<br>[e-mail] |
| Submission<br>Correspondent: | | Bill Jacqmein, Regulatory Affairs Consultant |
| Address: | Phone:<br>Email: | 11218 Zest Ct. NE, Blaine, MN 55449<br>[phone]<br>[e-mail] |
| Date Prepared: | | June 6th, 2018 |
| Proprietary Name: | | Smylio Invisible Clear Aligners |
| Common Name: | | Orthodontic Plastic Brackets |
| Product Code: | | NXC - Orthodontic Plastic Brackets |
| Device Classification: | | Class II, 21 CFR 872.5470 |
| Primary Predicate<br>Device: | | Derby Dental Laboratory Custom Clear Aligner System<br>(K173785) |
| Reference Predicates: | | 3Shape OrthoSystem™ Software (K152086)<br>ClearCorrect System (K113618) |

## Device Description:

The Smylio Invisible Clear Aligners are intraoral thermoformed plastic aligners that are worn 20 to 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.

Smylio Invisible 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.

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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 teeth into 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®.

#### Material:

The material used for the manufacturing validation in this submission is the Zendura®.

## Indications for Use:

The Smylio Invisible Clear Aligners is indicated for use in the alignment of permanent teeth through orthodontic treatment of misalignment and malocclusion.

## Comparison to Predicate Devices:

| Table 1: Functional Specification Comparison | | |
|----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Functional<br>Specification | Smylio Invisible Clear<br>Aligners | Custom Clear Aligner<br>System (K173785) |
| Material | Co-polyester or Co-Polymer | Co-polyester or Co-<br>Polymer |
| Mode of Action | Continuous gentle force<br>applied to teeth to achieve<br>movement | Continuous gentle force<br>applied to teeth to achieve<br>movement |
| Features: | | |
| Device Description | Sequential thermoformed<br>plastic aligners | Sequential thermoformed<br>plastic aligners |
| Patient<br>Removable? | Yes | Yes |
| Duration of Use | 20 to 22 hours per day | 20 to 22 hours per day |
| Indication for Use | The Smylio Invisible Clear<br>Aligners is indicated for use in<br>the alignment of permanent<br>teeth through orthodontic<br>treatment of misalignment<br>and malocclusion. | The Custom Clear Aligner<br>is indicated for use in the<br>alignment of permanent<br>teeth through orthodontic<br>treatment of misalignment<br>and malocclusion. |

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## Comparison of Indications for Use to Predicate Devices:

Based on the above comparison, the indications for use of the Smylio Invisible Clear Aligners is similar to that of the Derby Dental Custom Clear Aligner (K173785).

## Comparison of Technological Characteristics to Predicate Devices:

Based on the above comparison, the design and construction of the Smylio Invisible Clear Aligners is similar to that of the Derby Dental Custom Clear Aligner (K173785).

## Non-clinical performance testing:

## Manufacturing Validation

A manufacturing validation was performed to demonstrate the dimensional accuracy of the manufacturing process for Smylio Aligners. Three critical aspects of the manufacturing process were assessed for accuracy: digital dentition models from treatment planning, 3D printed molds, and the final thermoformed aligners.

An independent 3rd party software and digital calipers were used to perform point-to-point and critical displacement measurements.

All translational measurements were within 0.3 mm of the target input value and all rotational measurements were within 3° of the target input value, the predefined tolerance of the manufacturing process. There were no statistical differences in the intended and measured values observed from any of the groups. This test has met the pre-established acceptance criteria to demonstrate dimensional accuracy.

#### Biocompatibility

A biocompatibility assessment was conducted. The Smylio Invisible Clear Aligners have been tested and shown to be compliant with the following standards:

- · ISO 7405:2008 Dentistry Evaluation of biocompatibility of medical devices used in dentistry
## Clinical performance testing:

Clinical performance testing was not conducted.

## Conclusion:

Based on comparison of indications for use, technological characteristics, performance testing, biocompatibility assessment, we believe that Smylio Invisible Clear Aligners are substantially equivalent to the predicate devices.

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## Indications for Use

510(k) Number (if known) K173784

Device Name Smylio Invisible Clear Aligners

Indications for Use (Describe)

The Smylio Invisible Clear Aligners is indicated for use in the alignment teeth through orthodontic treatment of misalignment and malocclusion.

| Type of Use (Select one or both, as applicable) |
|------------------------------------------------------------------------------------|
| <span style="font-size:12px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) |
| <span style="font-size:12px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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