Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the physical aligners and the manual process involving a dental professional and standard dental software. There is no mention of AI or ML in the device description, intended use, or performance studies.

Therapeutic

Yes
The device is indicated for the "treatment of tooth malocclusion" and "repositions teeth by way of continuous gentle force," which describes a therapeutic action.

Diagnostic

No

The device is a treatment device, not a diagnostic one. It repositions teeth through physical force and does not assess or identify medical conditions.

SaMD (Software as a Medical Device)

No

The device description clearly states the device is a series of clear plastic aligners, which are physical components, not software. While software is used in the design process, the final device delivered to the patient is a physical product.

IVD (In Vitro Diagnostic)

Based on the provided information, the U-Aligner System is not an In Vitro Diagnostic (IVD) device.

Here's why:

IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
U-Aligner System Function: The U-Aligner System is a physical device (clear plastic aligners) used to mechanically reposition teeth. It directly interacts with the patient's teeth and mouth.
Lack of Specimen Analysis: The description does not mention any analysis of biological specimens. The system relies on physical molds of the teeth and digital planning based on those molds.

The U-Aligner System falls under the category of a medical device, specifically a dental device used for orthodontic treatment.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

NXC

Device Description

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 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

teeth

Indicated Patient Age Range

Not Found

Intended User / Care Setting

dental health professional (e.g. orthodontist or dentist)

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K173785

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K113618

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 872.5470 Orthodontic plastic bracket.

(a)
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.(b)
Classification. Class II.

Summary

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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

1

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 Lijh0919@gmail.com (562) 484-0500

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

4

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

Summary of Technical Characteristics

5

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

6

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.