U-Aligner

K191308 · Universal Orthodontic Laboratory, Inc. · NXC · Apr 23, 2020 · Dental

Device Facts

• Record ID: K191308
• Device Name: U-Aligner
• Applicant: Universal Orthodontic Laboratory, Inc.
• Product Code: NXC · Dental
• Decision Date: Apr 23, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5470
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The U-Aligner System is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). The U-aligner system repositions teeth by way of continuous gentle force.

Device Story

U-Aligner is a series of clear, removable, thermoformed polyurethane plastic trays; used for orthodontic treatment of tooth malocclusions. Dental professional (orthodontist/dentist) assesses patient, takes molds, and submits prescription; Universal Orthodontic Lab uses Ortho System software (K180941) to design incremental tooth movement plan; physician reviews/approves design; lab thermoforms trays. Trays provided to patient for sequential wear; patient removes trays for eating/cleaning; clinician monitors treatment progress. Continuous gentle force from trays gradually repositions teeth. Benefits include aesthetic orthodontic correction without conventional wires/brackets.

Clinical Evidence

No clinical data. Bench testing limited to internal manufacturing validation of dimensional accuracy and material biocompatibility testing (cytotoxicity, sensitization, irritation) per ISO 10993-1. Literature cited for incremental tooth moving forces of thermoplastic materials.

Technological Characteristics

Thermoformed polyurethane material; sequential aligner system; non-powered; mucosal membrane contact >30 days. Design based on digital tooth alignment software (Ortho System).

Indications for Use

Indicated for treatment of tooth malocclusion in patients with permanent dentition (all second molars).

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

• Custom Clear Aligner System - Derby Dental Laboratory (K173785)

Reference Devices

• ClearCorrect System - ClearCorrect LLC (K113618)
• Ortho System (K180941)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in large, bold, blue letters, and the word "ADMINISTRATION" in smaller, blue letters below.

April 23, 2020

Universal Orthodontic Laboratory Inc Jiahe Li Regulatory Affair Associate 11917 Front St. Norwalk, California 90650

Re: K191308

Trade/Device Name: U-Aligner Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: April 21, 2020 Received: April 21, 2020

Dear Jiahe Li:

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/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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for Srinivas "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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## Section IV

# Indications for Use Statement

510(k) Number (if known): K191308

Device Name: _ U-Aligner

Indications for Use:

The U-Aligner System is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). The U-aligner system repositions teeth by way of continuous gentle force.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ OR

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#### K191308 Section V

# 510(k) Summary

### Submitter:

Universal Orthodontic Lab 11917 Front St. Norwalk, CA 90650 Contact Person: Jiahe Li Requlatory Affairs Manager [e-mail] [phone]

## Date Summary Prepared:

May 1st, 2019

DEVICE NAME

TRADE NAME: U-Aligner

COMMON NAME: Sequential Aligner

DEVICE CLASSIFICATION: Aligner, Sequential

CLASSIFICATION PRODUCT CODE: NXC

## PREDICATE DEVICE

Primary Predicate - Custom Clear Aligner System - Derby Dental Laboratory - K173785 Reference Device - ClearCorrect System- ClearCorrect LLC - K113618

## DESCRIPTION OF DEVICE

The U-Aligner system is a series of clear plastic aligners that offer a solution for patients who want an aesthetic orthodontic treatment by utilizing a set of removable aligners to correct tooth

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malocclusions without the use of conventional wire and bracket orthodontic technology.

A dental health professional (e.g. orthodontist or dentist), using a standard personal computer prescribes the U-Aligner system based on an assessment of the patient's teeth, determines a course of treatment with the system, takes molds of the patient's teeth and completes a prescription form. Universal Orthodontic Lab then designs a series of plastic trays intended to gradually realign the patient's teeth in accordance with the physician's prescription using a standard dental software used for tooth alignment (Ortho System™, K180941). The prescribing physician reviews and approves the model scheme before the molds are produced. Once approved, Universal Orthodontic Lab produces 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 professional to gradually move the target teeth to the designed position. The dental care professional monitors treatment from the moment the first aligner is delivered to when the final aligner is delivered. The trays are held in place by pressure and can be removed by the patient at any time.

The technology is essentially identical to that used by a number of sequential aligner systems, including the two predicate devices.

## INDICATIONS FOR USE

The U-Aligner System is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). The aligner system repositions teeth by way of continuous gentle force.

| | U-Aligner | Primary Predicate-<br>Custom Clear<br>Aligner System<br>(K173785) | Reference Device-<br>ClearCorrect<br>System (K113618) | Substantial<br>equivalence |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| Product<br>Code | NXC | NXC | NXC | Yes |
| Device Class | Class II | Class II | Class II | Yes |
| Intended Use | U-Aligner is<br>indicated for the<br>treatment of<br>anterior tooth<br>malocclusions in<br>patients with<br>permanent dentition<br>(i.e. all second | The Custom Clear<br>Aligner System is<br>indicated for use in<br>the alignment of<br>permanent teeth<br>through orthodontic<br>treatment of<br>misalignment and | ClearCorrect<br>System is indicated<br>for the treatment of<br>anterior tooth<br>malocclusions in<br>patients with<br>permanent dentition<br>(i.e. all second | Yes |

## Summary of Technical Characteristics

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| | molars). | malocclusion | molars). | |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|
| Indications<br>for Use | The U-Aligner<br>System is indicated<br>for the treatment of<br>tooth malocclusion<br>in patients with<br>permanent dentition<br>(i.e. all second<br>molars). The U-<br>aligner system<br>repositions teeth by<br>way of continuous<br>gentle force. | The Custom Clear<br>Aligner System is a<br>series of clear,<br>lightweight, plastic<br>appliances indicated<br>for the<br>treatment of tooth<br>malocclusions in<br>patients with<br>permanent dentition<br>(i.e., all second<br>molars).<br>Utilizing a series of<br>incremental tooth<br>movements, it<br>sequentially<br>positions teeth by<br>way of continuous<br>gentle force. | ClearCorrect<br>System is indicated<br>for the treatment of<br>anterior tooth<br>malocclusions in<br>patients with<br>permanent dentition<br>(i.e. all second<br>molars). The Clear<br>Correct System<br>positions teeth by<br>way of continuous<br>gentle force. | Yes |
| Mode of<br>Action | Alignment of teeth<br>by application of<br>continuous gentle<br>force, by<br>sequential use of<br>preformed plastic<br>trays | Alignment of teeth<br>by application of<br>continuous gentle<br>force, by sequential<br>use of preformed<br>plastic trays | Alignment of teeth<br>by application of<br>continuous gentle<br>force, by<br>sequential use of<br>preformed plastic<br>trays | Yes |
| Method of<br>Use | Each preformed<br>plastic tray is worn<br>by the patient as<br>prescribed by the<br>dental practitioner,<br>usually a few<br>weeks prior to<br>using the next<br>sequential aligner<br>tray | Each preformed<br>plastic tray is worn<br>by the patient as<br>prescribed by the<br>dental practitioner,<br>usually a few<br>weeks prior to<br>using the next<br>sequential aligner<br>tray | Each preformed<br>plastic tray is worn<br>by the patient as<br>prescribed by the<br>dental practitioner,<br>usually a few<br>weeks prior to<br>using the next<br>sequential aligner<br>tray | Yes |
| Material | Thermoformed<br>polyurethane | Thermoformed<br>polyurethane | Thermoformed<br>polyurethane | Yes |

## Performance Testing

Due to the difficulty in evaluating this type of dental device in a laboratory environment, no direct performance bench testing of the aligners was performed. The use of thermoplastic materials for sequential aligners intended to treat malocclusions have been well documented in scientific literature regarding incremental tooth moving forces. The physical properties have been provided by the material manufacturer.

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An internal manufacturing validation was performed to demonstrate the dimensional accuracy of the manufacturing process for U-Aligners. The results show that the pre-planned location and position of tooth structures defined by the aligner is expected compared to the final finished thermoformed aligner.

## Biocompatibility Testing

The biocompatibility evaluation for the device was conducted in accordance with ISO 10993-1, Biological evaluation and testing within a risk management process -Guidance for Industry and Food and Drug Administration Staff" as recognized by FDA. The aligner is considered mucosal membrane contacting for a duration of greater than 30 days. The battery of testing included the following tests:

- Cytotoxicity
- Sensitization
- Irritation

The results of the testing met the requirements of the study protocols and the material is considered non-cytotoxic, non-sensitizing and is not an intracutaneous irritant. The results of the studies further support a determination of substantial equivalence.

## Conclusion

U-Aligner is considered to be substantially equivalent to the identified legally marketed predicate in terms of indications for use, design, technological characteristics, mode of action, performance, materials and biocompatibility.