Clear Aligner

K203688 · Wuxi EA Medical Instruments Technologies Limited. · NXC · Oct 8, 2021 · Dental

Device Facts

• Record ID: K203688
• Device Name: Clear Aligner
• Applicant: Wuxi EA Medical Instruments Technologies Limited.
• Product Code: NXC · Dental
• Decision Date: Oct 8, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5470
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Clear Aligners are indicated for the alignment of teeth during orthodontic treatment of malocclusion in patients with permanent dentition (i.e. all second molars).

Device Story

Clear Aligner system consists of series of doctor-prescribed, thin, clear plastic removable orthodontic appliances and proprietary 3D software. Input: digital model of patient's teeth from impression or intraoral scan. Software generates model transforms describing final treated state and interpolates intermediate states; computer setups relay information to rapid prototyping machines to produce physical models. Aligners fabricated via thermoforming on physical models using polyurethane or TPU+PETG composite. Traction accessory (Angel Button) made of thermoplastic polyurethane can be bonded to aligner surface using acrylic polyurethane adhesive. Used in clinical settings by dental practitioners; patients wear aligners sequentially to apply corrective forces to teeth. System facilitates orthodontic tooth movement; benefits include correction of malocclusion.

Clinical Evidence

Real-world data provided for traction accessory effectiveness; adverse event analysis reported <0.001% incidence rate since 2019. Non-clinical evidence includes biocompatibility (cytotoxicity, irritation, sensitization, acute/subchronic/genetic toxicity), software validation, and mechanical performance testing (shear/tensile strength, 3-year accelerated aging).

Technological Characteristics

Materials: thermoformed polyurethane or TPU+PETG composite. Traction accessory: thermoplastic polyurethane. Manufacturing: thermoforming on rapid-prototyped physical models. Connectivity: proprietary 3D software for digital modeling and treatment planning. Biocompatibility: ISO 10993 compliant. Sterilization: non-sterile.

Indications for Use

Indicated for alignment of teeth during orthodontic treatment of 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

• Angel Align System (K171674)

Reference Devices

• Invisalign System with Mandibular Advancement Feature (K181739)

Submission Summary (Full Text)

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October 8, 2021

Wuxi EA Medical Instruments Technologies Limited. % Ivy Wang Technical Manager Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Central Avenue Shanghai, Shanghai 200122 CHINA

Re: K203688

Trade/Device Name: Clear Aligner Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: June 28, 2021 Received: September 08, 2021

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.

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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.

Michael E. Adjodha, M.ChE. 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

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# Indications for Use

510(k) Number (if known) K203688

Device Name Clear Aligner

Indications for Use (Describe)

Clear Aligners are indicated for the alignment of teeth during orthodontic treatment of malocclusion in patients with permanent dentition (i.e. all second molars).

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Wuxi EA Medical Instruments Technologies Limited.

No.1619, Huishan Avenue, Huishan Economic Development Zone, Wuxi, Jiangsu Province, China

# 510(K) Summary

## K203688

Summary prepared date: 2021-10-06

#### A. Applicant:

Wuxi EA Medical Instruments Technologies Limited. Address: No.1619, Huishan Avenue, Huishan Economic Development Zone, Wuxi, Jiangsu Province, China Contact Person: Ms. Yan He Tel: [phone]

Submission Correspondent: Primary contact: Ms. Ivy Wang Shanghai SUNGO Management Consulting Co., Ltd. Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: [phone] Email: [e-mail] Secondary contact: Mr. Raymond Luo Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: [phone] Email: [e-mail]

#### B. Device:

Trade Name: Clear Aligner Common Name: Sequential Aligners Regulatory Information Classification Name: Aligner, Sequential Classification: Class II Product code: NXC Regulation Number: 21 CFR 872.5470 Review Panel: Dental

## C. Predicate device:

K171674 Angel Align System Smile Development Corp.

Reference device K181739 Invisalign System with Mandibular Advancement Feature

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Align Technology, Inc.

# D. Indications for use of the device:

Clear Aligners are indicated for the alignment of teeth during orthodontic treatment of malocclusion in patients with permanent dentition (i.e. all second molars).

# E. Device Description:

The Proposed Device is an update device to the previous cleared Angel Align System (K171674) including added optional traction accessory.

The Clear Aligner System consists of a series of doctor-prescribed, thin, clear plastic removable orthodontic appliances (aligners) and proprietary 3D software. The aligners gently move the patient's teeth in small increments from their original state to a more optimal, treated state.

The Clear Aligners are fabricated by thin thermoformed polyurethane or thermoformed multilayer copolyester and polyurethane composite (TPU +PETG) plastic. The corrective forces are generated via differences between current teeth arrangement and each step's aligner. They are designed to move the teeth to the target position and deliver desired clinical effect.

The traction accessory, also called "Angel Button", made of thermoplastic polyurethane can be selected and will be bonded to the outer surface of the aligner by adhesive made of acrylic polyurethane.

# F. Comparison to predicate device

The Clear Aligner is substantially equivalent in intended use, indications for use, mode of action, mode of use, design to the predicate Smile Angel Align (K171674). 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 provides a comparison of the subject and predicate device.

Table 1: Comparison to Predicate Device

| Device | Subject Device | Predicate Device | Reference Device | Result |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| Manufacturer | Wuxi EA Medical<br>Instruments<br>Technologies Limited. | Smile Development<br>Corp. | Align Technology,<br>Inc. | - |
| 510K number | K203688 | K171674 | K181739 | - |
| Model Name | Clear Aligner | Angel Align System | Invisalign System<br>with Mandibular<br>Advancement<br>Feature | - |
| Classification | Class II Device, NXC<br>(21 CFR 872.5470) | Class II Device, NXC<br>(21 CFR 872.5470) | Class II Device, NXC<br>(21 CFR 872.5470) | Same |
| Classification Name | Aligner, Sequential | Aligner, Sequential | Aligner, Sequential | Same |
| Indications for use | Clear Aligners are indicated for the alignment of teeth during orthodontic treatment of malocclusion in patients with permanent dentition (i.e. all second molars). | Angel Align System is indicated for the alignment of teeth during orthodontic treatment of malocclusion. | The Invisalign System is intended for the orthodontic treatment of malocclusion | Same |
| 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 2 weeks prior to being replaced by the next aligner in sequence. | Each appliance is worn by the patient as determined by the dental practitioner, generally 2 weeks prior to being replaced by the next aligner in sequence. | 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 |
| Description of Appliance Application | Removable | Removable | Removable | Same |
| Method of manufacturing | Thermoforming | Thermoforming | Thermoforming | Same |
| Manufacturing Method | A digital model of the patient's teeth is created from either | A digital model of the patient's teeth is created from either | A digital model of the patient's teeth is created from | Same |
| | | | | |
| | impression or directly<br>from an intraoral scan<br>of the patient's teeth.<br>From the digital<br>model, following a<br>dental practitioner's<br>prescription, the<br>software generates<br>model transforms<br>describing the<br>provisional final,<br>treated state and<br>then interpolates a<br>series of model<br>transforms that<br>represent<br>intermediate states of<br>alignment.<br>The resulting<br>computer "setups"<br>relay this information<br>to rapid prototyping<br>machines that<br>produce physical<br>positive models. The<br>aligners are produced<br>by thermoforming on<br>each physical model<br>to fabricate the<br>sequence of aligners. | impression<br>or<br>directly from an<br>intraoral scan of the<br>patient's teeth.<br>From the digital<br>model, following a<br>dental practitioner's<br>prescription,<br>software generates<br>model transforms<br>describing the<br>provisional final,<br>treated state and<br>then interpolates a<br>series of model<br>transforms that<br>represent<br>intermediate states<br>of alignment.<br>The resulting<br>computer "setups"<br>relay this<br>information to rapid<br>prototyping<br>machines that<br>produce physical<br>positive models. The<br>aligners are<br>produced<br>by<br>thermoforming on<br>each physical model<br>to<br>fabricate<br>the<br>sequence<br>of<br>aligners. | a PVS impression<br>or directly from an<br>intraoral scan of<br>the patient's teeth.<br>From the digital<br>model, following a<br>dental<br>practitioner's<br>prescription, the<br>software generates<br>model transforms<br>describing the<br>provisional final,<br>treated state and<br>then interpolates a<br>series of model<br>transforms that<br>represent<br>intermediate states<br>of alignment.<br>The<br>computer "setups"<br>relay<br>this<br>information<br>to<br>rapid prototyping<br>machines that<br>produce physical<br>positive models.<br>The aligners<br>are<br>produced<br>by<br>thermoforming on<br>each<br>physical<br>model to fabricate<br>the sequence of<br>aligners. | |
| Material | The clear aligner uses<br>either<br>1. Multilayer<br>thermoformed<br>copolyester<br>and<br>polyurethane<br>composite<br>or<br>2. Thermoformed | Thermoformed<br>polyurethane | The Invisalign<br>System uses either:<br>1. Multilayer<br>aromatic<br>thermoplastic<br>polyurethane<br>/copolyester.<br>or<br>2. thermoformed | Same with<br>the<br>reference<br>device. |
| | polyurethane | | polyurethane | |
| Traction<br>accessory | Yes<br>Thermoformed<br>polyurethane | No | No | Different.<br>Same<br>material as<br>aligner, no<br>new<br>concerns<br>raised. |
| OTC or Rx | Rx | Rx | Rx | Same |
| Sterile | No | No | No | Same |
| Biocompatibility | In compliance with<br>ISO 10993 | In compliance with<br>ISO 10993 | In compliance with<br>ISO 10993 | Similar.<br>Both are in<br>compliance<br>with<br>ISO<br>10993 |

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Wuxi EA Medical Instruments Technologies Limited. No.1619, Huishan Avenue, Huishan Economic Development Zone, Wuxi, Jiangsu Province, China

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No.1619, Huishan Avenue, Huishan Economic Development Zone, Wuxi, Jiangsu Province, China

#### G. Non-clinical Test

#### 1) 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
- Sensitization
- Acute Toxicity
- Subchronic toxicity
- Genetic Toxicity

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.

## 2) Software validation & risk analysis

The software system used in the process of clear aligner manufacturing has been verified and validated as per FDA Guidance "General Principles of Software Validation; Final Guidance for Industry and FDA Staff".

A Risk Analysis was performed according to ISO 14971:2019 and documentation was included in the 510(k) to assess the performance and safety of subject device.

## 3) Performance Testing

Verification and validation testing were conducted to demonstrate the Clear Aligner showed conformity with pre-established specifications and acceptance criteria. The shear and tensile strength testing performed for the Angel button were tested according to EA internal specifications and the

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results passed the pre-defined acceptance criteria.

A 3-year shelf life accelerated aging testing were conducted and the test results showed conformity with the pre-established specifications and acceptance criteria.

#### H. Clinical Test Conclusion

Real-world data was submitted to demonstrate that the traction accessory was effective to aid the movement of teeth and that an analysis of adverse events was provided that showed less than 0.001 % of adverse events were occurred since 2019.

#### 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 K171674.