Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a physical device (aligners) and associated software for ordering and processing, but there is no mention of AI or ML being used in the design, manufacturing process, or treatment planning. The software is described as having a "moderate" level of concern, which is less likely to involve complex AI/ML algorithms.

Therapeutic

Yes
The device is indicated for the treatment of tooth malocclusion, and it progressively repositions teeth to achieve a desired clinical effect, which aligns with the definition of a therapeutic device.

Diagnostic

No.

The device is a Custom-made Invisible Aligner designed for the treatment of tooth malocclusion by progressively repositioning teeth, which is a therapeutic function, not a diagnostic one.

SaMD (Software as a Medical Device)

No

The device description explicitly states the device is a series of physical dental aligners made of plastic material. While software is mentioned for ordering and processing, the core medical device is a physical product.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
Device Function: The Custom-made Invisible Aligners are physical devices used to apply force to teeth to correct malocclusion. They are used directly on the patient's teeth within the oral cavity.
Lack of Specimen Analysis: The description does not mention the collection or analysis of any biological specimens from the patient. The device's function is mechanical and directly applied to the anatomical site.

Therefore, the Custom-made Invisible Aligners fall under the category of a medical device used for treatment, not an In Vitro Diagnostic device used for diagnostic testing of specimens.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Custom-made Invisible Aligners is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e., all second molars). The Custom-made Invisible Aligners positions teeth by way of continuous gentle force.

Product codes

NXC

Device Description

The Custom-made Invisible Aligners System is a series of dental aligners that fabricated of clear, thin thermoformed plastic to progressively reposition the teeth. The product is made from a composite multilayer material with thermoplastic polyurethane and polyethylene terephthalate-1, 4-cyclohexanedimethanol ester (TPU+PETG). Corrective force to reposition the teeth is delivered via minor changes into a position in each subsequent aligner. They are designed to move the teeth to the target position and deliver desired clinical effect.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Oral cavity

Indicated Patient Age Range

patients with permanent dentition (i.e., all second molars)

Intended User / Care Setting

Not Found

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)

Bench testing has demonstrated that the device is in compliance with pertinent standards and specifications, the expectations of the dental community and the product labeling. Performance testing was performed to the subject device including thickness, appearance, odor, density, water absorption, dissolution, color stability, tear resistance, Tensile modulus of elasticity to demonstrate its effectiveness. Manufacturing accuracy validation were conducted to the Custom-made Invisible Aligners. Aligners from 12 different patient case were evaluated at the beginning, middle and end throughout the sequence. The accuracy of 3D molding and aligner molding are checked and meet the pre-established specification. The suitability, function and form of the aligner were checked and comparing it to the treatment design in the software, and the results were complied with the pre-established specifications and acceptance criteria. A 3-year shelf life was determined by accelerated aging testing. Performance testing were conducted after 81 days of accelerated aging under 60°C. The test results showed conformity with the pre-established specifications and acceptance criteria.

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

Not Found

Predicate Device(s)

K203624

Reference Device(s)

K181739

Predetermined Change Control Plan (PCCP) - All Relevant Information

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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April 17, 2023

Zhejiang Yinchili Medical Technology Co., Ltd. % Ivy Wang Technical Manager Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Central Avenue Shanghai, Shanghai 200122 China

Re: K223454

Trade/Device Name: Custom-made Invisible Aligners Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: January 16, 2023 Received: January 17, 2023

Dear Ivy Wang:

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,

Bobak Shirmohammadi -S

For Michael E. Adjodha, M. ChE., CQIA Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K223454

Device Name Custom-made Invisible Aligner

Indications for Use (Describe)

The Custom-made Invisible Aligners is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e., all second molars). The Custom-made Invisible Aligners positions teeth by way of continuous gentle force.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) Summary

(As requirement by 21 CFR 807.92)

A. Applicant:

Zhejiang Yinchili Medical Technology Co., Ltd. Address: North 4F, No.239 Yatai Road, Nanhu District, Jiaxing, Zhejiang, CHINA Contact Person: Ms. Xinyan Zhang Tel: +86- 15800780940 Email: zhangxinyan@smartee.cn Date of summary prepared: 2023-03-30

Submission Correspondent:

Primary contact: Ms. Ivy Wang Shanghai SUNGO Management Consulting Co., Ltd. Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: haiyu.wang@sungoglobal.com Secondary contact: Mr. Raymond Luo Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: fda.sungo@gmail.com

B. Device:

Trade Name: Custom-made Invisible Aligners Common Name: Sequential Aligners Model: YCL-C Regulatory Information Classification Name: Aligner, Sequential Classification: Class II Product code: NXC Regulation Number: 21 CFR 872.5470 Review Panel: Dental

C. Predicate device:

K203624 (Primary Predicate) Custom-made Invisible Aligners Zhejiang Yinchili Medical Technology Co., Ltd.

Reference device K181739 Invisalign System with Mandibular Advancement Feature Align Technology, Inc.

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K223454

D. Indications for use of the device:

The Custom-made Invisible Aligners is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e., all second molars). The Custom-made Invisible Aligner positions teeth by way of continuous gentle force.

E. Device Description:

The Custom-made Invisible Aligners System is a series of dental aligners that fabricated of clear, thin thermoformed plastic to progressively reposition the teeth. The product is made from a composite multilayer material with thermoplastic polyurethane and polyethylene terephthalate-1, 4-cyclohexanedimethanol ester (TPU+PETG). Corrective force to reposition the teeth is delivered via minor changes into a position in each subsequent aligner. They are designed to move the teeth to the target position and deliver desired clinical effect.

F. Comparison to predicate device

The Custom-made Invisible Aligners is substantially equivalent in intended use, indications for use, mode of action, mode of use, design, and manufacturing to the predicate device. Only minor differences exist between the subject product and the predicate, which do not affect the safety or effectiveness of the subject device.

Table 1: Comparison to Predicate Device
Device	Subject Device	Predicate Device	Reference Device	Result
510K number	K223454	K203624	K181739	-
Model Name	Custom-made Invisible
Aligners	Custom-made
Invisible Aligners	Invisalign System
with Mandibular
Advancement
Feature	-
Classification	Class II Device, NXC (21
CFR 872.5470)	Class II Device, NXC
(21 CFR 872.5470)	Class II Device, NXC
(21 CFR 872.5470)	Same
Classification
Name	Aligner, Sequential	Aligner, Sequential	Aligner, Sequential	Same
Indications for
use	The Custom-made
Invisible Aligners is
indicated for the
treatment of tooth
malocclusion in
patients with
permanent dentition
(i.e., all second molars).
The Custom-made
Invisible Aligner
positions teeth by way
of continuous gentle	The Custom-made
Invisible Aligners is
indicated for the
treatment of tooth
malocclusion in
patients with
permanent dentition
(i.e., all second
molars). The
Custom-made
Invisible Aligner
positions teeth by way	The Invisalign
System is intended
for the orthodontic
treatment of
malocclusion.	Same
	force.	of continuous gentle force.
Mode of
Action	Orthodontic tooth
movement occurs
through forces applied
by the device to the
dentition as each tooth
follows the
programmed
displacement based on
a doctor's prescription.	Orthodontic tooth
movement occurs
through forces
applied by the device
to the dentition as
each tooth follows the
programmed
displacement based
on a doctor's
prescription.	Orthodontic tooth
movement occurs
through forces
applied by the
device to the
dentition as each
tooth follows the
programmed
displacement
based on a doctor's
prescription.	Same
Anatomical
Site of Use	Oral cavity	Oral cavity	Oral cavity	Same
Mode of Use	Each aligner is worn by
the patient as
determined by the
treating dental
practitioner, generally
for 22 hrs/day (or full
time except for eating
and hygiene) for 2
weeks prior to being
replaced by the next
aligner in sequence.
This is repeated for a
duration as prescribed
by a Dental
Professional.	Each aligner is worn by
the patient as
determined by the
treating dental
practitioner, generally
for 22 hrs/day (or full
time except for eating
and hygiene) for 2
weeks prior to being
replaced by the next
aligner in sequence.
This is repeated for a
duration as prescribed
by a Dental
Professional.	Aligners are worn
for approximately
1-2 weeks of 20-22
hours of wear per
day, after which it
is replaced by the
next stage aligners.
This is repeated for
duration as
prescribed by the
Dental Practitioner	Same
Application	Removable	Removable	Removable	Same
Raw Material
Used	Multilayer
(Thermoplastic
polyurethane) + PETG
(Polyethylene
terephthalate-1,
4-cyclohexanedimethan
ol ester)	TPU Thermoplastic
copolyester
(polyethylene
terephthalate-ethylen
e glycol copolyester)	The Invisalign
System uses either:

Multilayer
aromatic
thermoplastic
polyurethane
/copolyester.
or
thermoformed
polyurethane | Same
with the
reference
device. |
| Method of
Manufacturing | Thermoforming | Thermoforming | Thermoforming | Same |
| OTC or Rx | Rx | Rx | Rx | Same |
| Sterile | No | No | No | Same |
| Biocompatibility | In compliance with ISO 10993, tests including
Cytotoxicity
Oral Mucosa Irritation
Sensitization
Sub chronic systemic toxicity
Genotoxicity | In compliance with ISO 10993, tests including
Cytotoxicity
Oral Mucosa Irritation
Sensitization | In compliance with ISO 10993 | Similar.
Both are in compliance with ISO 10993 |
| Design | Image: Clear aligner | Image: Clear aligner | Not available | Similar.
Both are transparent plastic films. |

Table 1 provides a comparison of the subject and predicate device.

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6

K223454

G. Non-clinical Test

1) Performance Testing

Bench testing has demonstrated that the device is in compliance with pertinent standards and specifications, the expectations of the dental community and the product labeling. Performance testing was performed to the subject device including thickness, appearance, odor, density, water absorption, dissolution, color stability, tear resistance, Tensile modulus of elasticity to demonstrate its effectiveness.

Manufacturing validation accuracy testing

Manufacturing accuracy validation were conducted to the Custom-made Invisible Aligners. Aligners from 12 different patient case were evaluated at the beginning, middle and end throughout the sequence. The accuracy of 3D molding and aligner molding are checked and meet the pre-established specification. The suitability, function and form of the aligner were checked and comparing it to the treatment design in the software, and the results were complied with the pre-established specifications and acceptance criteria.

Shelf life – 3 years

A 3-year shelf life was determined by accelerated aging testing. Performance testing were conducted after 81 days of accelerated aging under 60°C. The test results showed conformity with the pre-established specifications and acceptance criteria.

2) Biocompatibility Testing

The biocompatibility evaluation for the device was conducted in accordance with "Use of International Standard 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 testing included the following tests:

Cytotoxicity ●
Irritation

7

K223454

Sensitization
Sub chronic systemic toxicity
Genotoxicity

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

Software Verification and Validation Testing

Software verification and validation testing were conducted on the software that facilitates ordering and processing of the Custom-made Invisible Aligner to support that the device is as safe and effective as the predicates. Documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern.

H. Clinical Test Conclusion

No clinical study is included in this submission.

l. Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device K203624.