UniSmile Clear Aligner System

K191837 · Vitang Technology, LLC · NXC · Jan 29, 2020 · Dental

Device Facts

• Record ID: K191837
• Device Name: UniSmile Clear Aligner System
• Applicant: Vitang Technology, LLC
• Product Code: NXC · Dental
• Decision Date: Jan 29, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5470
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The UniSmile Clear Aligner System is indicated for the treatment of tooth malocclusion in patients with permanent dentition. The UniSmile Clear Aligner System positions teeth by way of continuous gentle force.

Device Story

UniSmile Clear Aligner System consists of series of clear, removable, thermoformed plastic aligners; used for aesthetic orthodontic treatment to incrementally move teeth from original to treated state. Dental professionals submit patient cases; images of teeth structures transformed into 3D data. Treatment plans designed using Orchestrate 3D (OrthoRx 4) software; plans reviewed and approved by dental practitioner. Aligners manufactured via thermal forming on digitally printed models. Each aligner worn by patient for defined period (e.g., 2 weeks) to apply continuous gentle force to teeth. System is prescription-only; intended for use in clinic/home settings. Benefits include correction of malocclusions through programmed displacement based on doctor's prescription.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993-1, including cytotoxicity, intracutaneous/intradermal reactivity, and sensitivity. Performance properties (tensile modulus and strength) verified as acceptable for orthodontic base material.

Technological Characteristics

Clear thermoformed thermoplastic copolyester aligners; 80 ± 2 Shore D durometer hardness. Non-sterile, single-use. Software-driven design (Orchestrate 3D). Biocompatible per ISO 10993.

Indications for Use

Indicated for treatment of tooth malocclusion in patients with permanent dentition.

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

• ClearCorrect System (K113618)

Reference Devices

• Orchestrate 3D (K181112)

Submission Summary (Full Text)

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January 30, 2020

Vitang Technology, LLC Xiangxu Chen Vice President of Regulatory and R&D 14662 Franklin Ave, Unit H Tustin, California 92780

Re: K191837

Trade/Device Name: UniSmile Clear Aligner System Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic plastic bracket Regulatory Class: Class II Product Code: NXC Dated: October 25, 2019 Received: November 1, 2019

Dear Xiangxu Chen:

This letter corrects our substantially equivalent letter of January 29, 2020.

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,

For Srivinas 'Nandu' Nandkumar, Ph.D. Director DHT1B: Division of Dental 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) K191837

Device Name UniSmile Clear Aligner System

Indications for Use (Describe)

The UniSmile Clear Aligner System is indicated for the treatment of tooth malocclusion in patients with permanent dentition. The UniSmile Clear Aligner System positions teeth by way of continuous gentle force.

Type of Use (Select one or both, as applicable)

| <span> <span style="font-size: 14px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|-------------------------------------------------------------------------------------------------------|
|-------------------------------------------------------------------------------------------------------|

| <span> <span style="font-size: 14px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
|------------------------------------------------------------------------------------------------------|
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Image /page/3/Picture/0 description: The image contains the logo for Vitang Technology. The logo consists of a blue geometric shape resembling the letter 'T' on the left. To the right of the shape is the company name, 'Vitang Technology', with 'Technology' in a slightly lighter shade of blue. The text 'K191837' is at the top of the image.

Vitang Technology, LLC Traditional 510(k) Premarket Submission Vitang UniSmile Clear Aligner System

## K191837

## 510(k)Summary

# UniSmile Clear Aligner System

| Submitter Name: | Vitang Technology LLC |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Address: | 14662 Franklin Ave, Unit H, Tustin, CA 92780 |
| Phone Number: | 773-236-7691 |
| Contact Person: | Xiangxu Chen |
| Date Prepared: | 1/29/2020 |
| Device Trade Name: | UniSmile Clear Aligner System |
| Common Name: | Aligner, sequential |
| Classification Name: | Orthodontic Plastic Bracket |
| Classification<br>Number: | 21 CFR 872.5470 |
| Product Code: | NXC |
| Regulatory Class | 2 |
| Primary Predicate | K113618, ClearCorrect System |
| Reference Device | K181112, Orchestrate 3D |
| Device Description | The UniSmile Clear Aligner System is fabricated of clear thin<br>thermoformed plastics in a sequential series to progressively<br>reposition the teeth. Corrective force to reposition the teeth is<br>delivered via minor changes into a position in each subsequent<br>aligner. |
| Indications for Use | The UniSmile Clear Aligner System is indicated for the treatment of<br>tooth malocclusion in patients with permanent dentition. The<br>UniSmile Clear Aligner System positions teeth by way of continuous<br>gentle force. |
| Summary of Usage | UniSmile Clear Aligner System consists of a series of clear<br>plastic aligners that offer a solution for aesthetic orthodontic<br>treatment by utilizing a set of removable aligners to incrementally<br>move the patient's teeth from an original state to a treated state that<br>corrects tooth malocclusions.<br>Cases are submitted by the dental professionals and images of<br>patient teeth structures are transformed to three-dimensional data<br> |
| Design and<br>Manufacturing Flow<br>chart | This is a device that requires prescription by order of a dental practitioner. Based on the patient information from a dental practitioner, the treatment plan is designed with a software. The treatment plan is then forwarded to the dental practitioner for review. Once approved, the aligners are manufactured by thermal forming on digitally printed models. Clear aligners are delivered to the practitioner. Each aligner is used by the patient, with instructions. |
| | Page 2 of 4 |
| | • Each aligner is designed for single use within a defined period<br>of time, such as 2 weeks/aligner.<br>• It is not sterilized.<br>• It does not contain drugs or biological substances.<br> |
| Software | Software is used to design treatment plans. The software used with<br>UniSmile Clear Aligner System is the Orchestrate 3D (K181112)<br>software, version OrthoRx 4. |
| Clear Aligner<br>Materials Testing | Performance properties have been tested and approved for clear<br>aligner applications. |
| Biocompatibility | Biocompatibility testing has been provided according to ISO-10993 |

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Image /page/4/Picture/0 description: The image contains the logo for Vitang Technology, along with the identifier K191837. The logo features a stylized letter 'T' in shades of blue, presented in a three-dimensional form. To the right of the 'T' is the company name, 'Vitang Technology,' with 'Vitang' in a darker blue and 'Technology' in a lighter blue hue.

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Image /page/5/Picture/0 description: The image contains the logo for Vitang Technology. The logo consists of a stylized blue "T" shape on the left and the words "Vitang Technology" in blue on the right. The word "Technology" is slightly smaller and a lighter shade of blue than the word "Vitang". There is also a serial number "K191837" at the top of the image.

### Comparison with Predicate Device

| | UniSmile Clear<br>Aligners | ClearCorrect System | Comparison |
|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | K191837 | K113618 | |
| Regulation number | 21 CFR 872.5470 | 21 CFR 872.5470 | same |
| Device<br>common/classification<br>name | Aligner, sequential | Sequential Aligner | same |
| Product Code | NXC | NXC | |
| Indications for use | The UniSmile Clear Aligner<br>System is indicated for the<br>treatment of tooth<br>malocclusion in patients with<br>permanent dentition. The<br>UniSmile Clear Aligner<br>System positions teeth by<br>way of continuous gentle<br>force. | The ClearCorrect System is<br>indicated for the treatment<br>of tooth malocclusion in<br>patients with permanent<br>dentition (i.e. all second<br>molars). The ClearCorrect<br>System positions teeth by<br>way of continuous gentle<br>force. | Same |
| Device Description | The UniSmile Clear Aligner<br>System is fabricated of clear<br>thin thermoformed plastics in<br>a sequential series to<br>progressively reposition the<br>teeth. Corrective force to<br>reposition the teeth is<br>delivered via minor changes<br>into a position in each<br>subsequent aligner. | The ClearCorrect device<br>is fabricated of clear thin<br>thermoformed<br>polyurethane plastic in a<br>sequential series to<br>progressively reposition<br>the teeth. Corrective<br>force to straighten the<br>teeth is delivered via<br>minor changes into a<br>position in each subsequent<br>aligner. | Same |
| Mode of Action | A set of removable aligners<br>incrementally move the | Orthodontic tooth<br>movement occurs | Same |
| | patient's teeth from an<br>original state to a treated<br>state through forces applied<br>by the appliance that corrects<br>tooth malocclusions. The<br>programmed displacement is<br>based on a doctor's<br>prescription. | through forces applied by<br>the appliance to the<br>dentition as each tooth<br>follows the programmed<br>displacement based on a<br>doctor's prescription. | |
| Anatomy Location | Mouth, mucosal membranes | Mouth, mucosal membranes | Same |
| Size/Dimension | Patient and treatment<br>progress specific | Patient and treatment<br>progress specific | Same |
| Method of<br>Manufacturing | Thermoforming | Thermoforming | Same |
| Material | Thermoplastic copolyester | Thermoplastic polyurethane | Similar. Both are<br>thermoplastic<br>forming<br>materials that do<br>not raise any<br>additional<br>questions of safety<br>or efficacy |
| Material Hardness | $80 \pm 2$ Shore D durometer | $80 \pm 2$ Shore D durometer | Same |
| Material Tensile<br>Modulus | Tensile modulus is<br>acceptable for as an<br>orthodontic base material | Information not available | Good for<br>orthodontic clear<br>aligner<br>applications |
| Material Tensile<br>Strength | Tensile strength is acceptable<br>for as an orthodontic base<br>material | Information not available | Good for<br>orthodontic clear<br>aligner<br>applications |
| Biocompatibility | Passed ISO 10993-1<br>assessment<br>• Cytotoxicity<br>• Intracutaneus Intradermal<br>reactivity<br>• Sensitivity | Passed ISO 10993-1<br>asseessment<br>• Cytotoxicity<br>• Intracutaneus Intradermal<br>reactivity | Same |

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Image /page/6/Picture/0 description: The image contains the text "K191837" at the top. Below that is a logo for "Vitang Technology". The logo consists of a blue geometric shape resembling a stylized letter "T" on the left, followed by the company name in blue font, with the "ec" in "Technology" being a lighter shade of blue.

Conclusion of Substantial Equivalence

UniSmile Clear Aligner System have substantially equivalent Indications for Use as the identified predicate and reference devices. UniSmile Clear Aligner System are substantially equivalent to the predicate device in the technological characteristics, design and device features.