The Orthodontic Appliance is indicated for the correction of tooth malocclusion in patients with permanent dentition. The Orthodontic Appliance moves the teeth by continuous gentle force.

Device Description

The Orthodontic Appliance is a series of clear, lightweight, plastic aligners that are used to replace traditional orthodontic wires and brackets for the alignment of maloccluded or misaligned teeth. This series of aligners moves the teeth gently, and in small increments, from their original to their final treated position for improved dental alignment. The product is made of a polymer thermoplastic material (polyvinyl ester mixture) by pressing.

The doctor-prescribed Orthodontic Appliance are provided non-sterile and are customized for each patient according to the 3D printed data designed by Clear Aligner Design Software. Shandong Huge Dental Material Corporation manufactures the Orthodontic Appliance by thermoforming commercially available thermoplastic material and send them to the clinician. The clinician confirms the fit of the aligners upon delivery to the patient and monitors the patient's progress throughout treatment. Depending on the patient need and the treatment plan, a series of aligners may be used. The duration of use for each pair of appliance is 2-3 weeks, wear the appliances for at least 20 hours every day and it is to be worn except during eating or cleaning of the oral cavity.

The type of Orthodontic Appliance is LX-A with various thickness so that the clinician can select suitable thickness based on patients' teeth micromaxillary deformity conditions. Different thickness are identical in chemical compositions, indications for use, functions, performance characteristics, operation principle and other aspects.

AI/ML Overview

The provided document is a 510(k) summary for an Orthodontic Appliance. It details the device's indications for use, its description, comparison to a predicate device, and non-clinical performance testing. However, it explicitly states that no clinical testing was required or performed to support the device's clearance.

Therefore, many of the requested details regarding acceptance criteria and a study proving the device meets those criteria cannot be extracted from this document, as such a study was not conducted for human performance. The focus of the provided document is on demonstrating substantial equivalence to a predicate device through non-clinical means (material properties, biocompatibility, and software V&V for ordering/processing).

Here's what can be extracted based on the information provided:

Acceptance Criteria and Device Performance (Non-Clinical)

Since no clinical study was performed, the "device performance" relies on non-clinical tests and comparison to a predicate. The acceptance criteria essentially stem from demonstrating that the subject device is comparable to the predicate device in terms of performance characteristics.

Acceptance Criteria (What was tested for)	Reported Device Performance (Met, or comparable to predicate)
Physical and Mechanical Properties:	The document states: "The performance testing for the subject device was performed and showed that the subject device meets all internal final inspection standard, while the physical and mechanical properties as well as the biocompatibility of the thermoplastic materials used to fabricate the aligners have previously been demonstrated by the manufacturer of the base materials." Specific tested items included:Appearance and surface characteristicsDimensionspH valueElasticity variableVolume weightWater sorptionSolubilityThe comparative testing between the proposed and predicate device for these properties was conducted to demonstrate substantial equivalence. The implication is that the subject device's performance aligns with or is sufficiently similar to the predicate device and established material properties.
Biocompatibility (ISO 10993 Standards):	The document states: "Biocompatibility tests were performed to satisfied the ISO 10993 standards. The test results of the tests met the requirements of the study protocols..." Specific tests conducted:Cytotoxicity (ISO 10993-5)Skin Sensitization (ISO 10993-10)Intracutaneous Reactivity (ISO 10993-10)Subchronic systemic toxicity (ISO 10993-11)Genotoxicity (ISO 10993-3)The results indicated the device met the requirements, supported by the long history of safe use of the thermoplastic material and the predicate device's information.
Software Verification & Validation:	The document states: "Software verification and validation testing were conducted on the software that facilitates ordering and processing of the Orthodontic Appliance to support that the device is as safe and effective as the predicates. Documentation was provided as recommended by FDA's Guidance... The software for this device was considered as a 'moderate' level of concern." This indicates that the software was tested and verified to perform its intended functions related to device ordering and processing, meeting the requirements for its risk classification.

Study Details (Based on the document's claims of no clinical testing required)

Many of these categories are not applicable (N/A) because the submission explicitly states:
"The performance of Orthodontic Appliance in the clinical environment has been well established since the first such devices were cleared by the FDA in 1998 under product code NXC. Therefore, there was no clinical testing required to support Orthodontic Appliance, as the indications for use is equivalent to the predicate device."

Sample sizes used for the test set and the data provenance:
- Clinical Test Set: N/A (No clinical test set was used for human performance evaluation).
- Non-Clinical Test Set: Not specified in terms of sample numbers, but tests were performed on material samples and the device itself (e.g., for dimensions, appearance, physical/chemical properties). Data provenance is from Shandong Huge Dental Material Corporation's internal testing and material suppliers' data.
  - Biocompatibility Tests: Sample sizes for ISO 10993 tests are not explicitly mentioned in this summary, but these are standard lab tests performed on material extracts or samples.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (No clinical ground truth was established as no clinical study was performed for this 510(k)).
Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A (No clinical test set requiring adjudication).
If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: N/A (No MRMC study was performed as no clinical study was conducted, and the device is a physical appliance, not an AI-based diagnostic tool for human readers).
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A (The device is a physical appliance, not an algorithm, and no standalone clinical performance was evaluated). Non-clinical standalone tests were performed as detailed in the table above (physical/mechanical properties, biocompatibility).
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): N/A (No clinical ground truth as no clinical study for human performance was conducted. For non-clinical tests, "ground truth" would be the established ISO standards and material specifications).
The sample size for the training set: N/A (The device is a physical orthodontic appliance, not a machine learning model. Therefore, there's no "training set" in the context of an AI/ML device). The design of the appliance is based on 3D printed data generated by "Clear Aligner Design Software", but this itself is part of the manufacturing process, not a training set for an AI algorithm.
How the ground truth for the training set was established: N/A (No training set for an AI/ML model).

Summary

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Indications for Use

510(k) Number (if known) K181747

Device Name Orthodontic Appliance

Indications for Use (Describe)

The Orthodontic Appliance is indicated for the correction of tooth malocclusion in patients with permanent dentition. The Orthodontic Appliance moves the teeth by continuous gentle force.

Type of Use (Select one or both, as applicable)
× Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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005 510 (k) Summary

This summary of 510(k) is being submitted in accordance with the requirements of 21 C.F.R. 807.92.

1. Date Summary Prepared: April 14, 2019

2. Submitter Information:

Name	Shandong Huge Dental Material Corporation
Address	No. 68 Shanhai Road, Donggang District, Rizhao City,Shandong Province, 276800, P. R. China
Telephone	+86 633 2277285
Fax	+86 633 2277298
Contact	Ms. Maggie Zheng
E-mail	zhengxy@hugedent.com

3. Device Name:

Trade name: Orthodontic Appliance

Common name: Aligner, Sequential

Classification name: Orthodontic plastic bracket

4. Substantially Equivalent Device:

Company Name	Device Name	510 (k) NO.	Substantially Equivalent(SESE) Decision Date
ClearPath Orthodontics Ltd	ClearPath Aligner	K162609	09/19/2016

No reference devices were used in this submission.

5. Description of Device:

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6. Intended for Use / including the indications for use:

The Orthodontic Appliance is indicated for the correction of tooth malocclusion in patients with permanent dentition. The Orthodontic Appliance moves the teeth by continuous gentle force.

7. Mechanism of Action:

The mechanism of action is similar to the predicate device and supports a determination of substantial equivalence. Orthodontic tooth movement occurs through continuous gentle force applied to the teeth by the appliance based on a healthcare practitioner's prescription.

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8. Technological Characteristics:

Treatment of tooth malocclusions via a series of plastic appliances that incrementally moves the teeth to a desired final position is the technological principle for both the subject device and the predicate device. A comparison of technological characteristics between the subject device and the predicate device has been performed. The results of this comparison demonstrate that the indications for use, design, technological characteristics, mechanism of action, performance, materials and biocompatibility are substantially equivalent.

Table 3: Device Comparison Table
Comparison Items	Subject Device	Predicate Device
Device Name	Orthodontic Appliance	ClearPath Aligner
510 (k) Number	To be determined	K162609
Regulation Number	21 C.F.R. 872.5470	21 C.F.R. 872.5470
Product Code	NXC	NXC
Classifications	Class II	Class II
Indications for use	The Orthodontic Appliance is indicatedfor the correction of tooth malocclusionin patients with permanent dentition.The Orthodontic Appliance moves theteeth by continuous gentle force.	The ClearPath Aligner is a series ofclear, lightweight, plastic appliancesindicated for the correction of dentalmalocclusion in patients withpermanent dentition (i.e. all secondmolars). The ClearPath Aligner isintended to position teeth by way ofcontinuous gentle force.
Material	Thermoplastic material	Thermoplastic material
Mechanism of Action	Continuous gentle force applied to teethto achieve movement.	Continuous gentle force applied to teethto achieve movement.
Manufacturing method	Thermoforming.	Thermoforming.
Conditions of Use	The duration of use for each pair ofappliance is 2-3 weeks, wear theappliances for at least 20 hours everyday and it is to be worn except duringeating or cleaning of the oral cavity.	The duration of use for each pair ofappliance is 2-3 weeks, wear theappliances for at least 20 hours everyday and it is to be worn except duringeating or cleaning of the oral cavity.

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Shandong Huge Dental Material Corporation www.hugedental.com T / +86 633 2277285 F / +86 633 2277298

No.68 Shanhai Road, Donggang District, Rizhao Shandong Province, 276800, P.R.China

Table 3: Device Comparison Table
Comparison Items	Subject Device	Predicate Device
Device Name	Orthodontic Appliance	ClearPath Aligner
510 (k) Number	To be determined	K162609
The treatment plan varies by individualpatient prescription.	The treatment plan varies by individualpatient prescription.	The treatment plan varies by individualpatient prescription.
Biocompatibility	Biocompatible	Biocompatible
Sterility	Non-sterile	Non-sterile
Anatomical Site	Used by dentist or orthodontist onteeth for dental patients.	Used by dentist or orthodontist on teethfor dental patients.

9. Summary of Non-Clinical Performance Testing:

There is no international/industrial standards regarding the performance of this product. The performance testing for the subject device was performed and showed that the subject device meets all internal final inspection standard, while the physical and mechanical properties as well as the biocompability of the thermoplastic materials used to fabricate the aligners have previously been demonstrated by the manufacturer of the base materials.

The test items include appearance and surface characteristics, dimensions, pH value, elasticity variable, volume weight, water sorption, solubility. Meanwhile, the comparative testing was conducted between the proposed and the predicate device to determine substantial equivalence.

10. Summary of Biocompatibility:

The thermoplastic material used for fabrication of the aligners is commonly used in many dental appliances, which has a long history of safe and biocompatible use for this purpose. And there is sufficient information from the predicate device to demonstrate that this product provide reasonable assurance of safety and effectiveness. The formulation of the subject device does not contain any new or non-conventional chemicals compared to the legally marketed predicate device.

Biocompatibility tests were performed to satisfied the ISO 10993 standards. The test results of

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the tests met the requirements of the study protocols, the tests including Cytotoxicity (ISO 10993-5), Skin Sensitization (ISO 10993-10), Intracutaneous Reactivity (ISO 10993-10), Subchronic systemic toxicity (ISO 10993-11) and Genotoxicity (ISO 10993-3).

11. Summary of Clinical Performance Data:

The performance of Orthodontic Appliance in the clinical environment has been well established since the first such devices were cleared by the FDA in 1998 under product code NXC. Therefore, there was no clinical testing required to support Orthodontic Appliance, as the indications for use is equivalent to the predicate device.

The substantial equivalence of the subject device to the ClearPath Aligner is supported by the non-clinical testing that was performed, along with other supporting documentation, and presented in this submission.

12. Software Verification and Validation Testing

Software verification and validation testing were conducted on the software that facilitates ordering and processing of the Orthodontic Appliance 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.

13. Summary of Substantial Equivalence

The subject device, Orthodontic Appliance, has substantially equivalent Indications for Use as the identified predicate device. While the verbiage of the Indications of Use of the subject device is minor different than the declared predicate device; however, these minor differences are not of significance and do not alter the intended therapeutic use of the device as compared to the predicate device.

The conclusions drawn from the data included in this submission, demonstrates that the subject

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device, Orthodontic Appliance, is substantially equivalent to the predicate device in indications for use, design, technological characteristics, mechanism of action, performance, materials and biocompatibility.

14. Photo of the device

Image /page/6/Picture/5 description: The image shows a clear plastic dental aligner on a black reflective surface. The aligner is designed to fit over the teeth and is used to straighten them over time. The aligner is transparent, which makes it less noticeable than traditional braces. The reflection of the aligner on the black surface creates a mirror image, enhancing the visual appeal of the photograph.

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April 18, 2019

Shandong Huge Dental Material Corporation Maggie Zheng Regulatory Affairs Manager No. 68 Shanhai Road, Donggang District Rizhao City, Shandong Province 276800 PEOPLE'S REPUBLIC OF CHINA

Re: K181747

Trade/Device Name: Orthodontic Appliance Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: March 6, 2019 Received: March 11, 2019

Dear Maggie Zheng:

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

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.