SmileAlign Orthodontic Aligner System

K191774 · 3D Global Biotech, Inc. · NXC · Sep 30, 2019 · Dental

Device Facts

• Record ID: K191774
• Device Name: SmileAlign Orthodontic Aligner System
• Applicant: 3D Global Biotech, Inc.
• Product Code: NXC · Dental
• Decision Date: Sep 30, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5470
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SmileAlign® Orthodontic Aligner System is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e., all second molars). The SmileAlign Orthodontic Aligner System positions teeth by way of continuous gentle force.

Device Story

SmileAlign Orthodontic Aligner System consists of series of clear, thin thermoformed PETG plastic aligners; designed to progressively reposition teeth via continuous gentle force. Dental practitioner uses 3Shape Ortho System software to generate/review model schemes; practitioner approves treatment plan before fabrication. Patient wears aligners sequentially, typically replacing every 2 weeks as prescribed. Device used in clinical setting under professional supervision. Benefits include correction of malocclusion through programmed tooth displacement.

Clinical Evidence

No clinical data included. Bench testing only: biocompatibility (ISO 10993-5 cytotoxicity, ISO 10993-10 irritation/sensitization) and material properties (tensile strength, compression strength, water absorption, density, pH change) passed.

Technological Characteristics

Material: PETG (thermoplastic polymer). Form factor: clear, thin thermoformed aligners. Principle: continuous gentle force via sequential programmed displacement. Software: 3Shape Ortho System used for modeling/planning. Biocompatibility: ISO 10993 compliant.

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

• Byte Aligner System (K180346)

Reference Devices

• 3Shape Ortho System (K152086)

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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.

September 30, 2019

3D Global Biotech Inc. % Diana Lam Regulatory Affairs Consultant DuoCare, LLC 370 W Grand Blvd #110. Corona, California 92882

Re: K191774

Trade/Device Name: SmileAlign Orthodontic Aligner System Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: July 2, 2019 Received: July 2, 2019

Dear Diana Lam:

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

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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 medical devices and radiation-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 Nandkumar, Ph.D. Acting 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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# Indications for Use

510(k) Number (if known) K191774

Device Name SmileAlign® Orthodontic Aligner System

Indications for Use (Describe)

The SmileAlign® Orthodontic Aligner System is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e., all second molars). The SmileAlign Orthodontic Aligner System positions teeth by way of continuous gentle force.

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

| <div> <span> <svg height="12" width="12"> <rect fill="none" height="12" stroke="black" width="12"></rect> <line stroke="black" x1="0" x2="12" y1="0" y2="12"></line> <line stroke="black" x1="0" x2="12" y1="12" y2="0"></line> </svg> </span> Prescription Use (Part 21 CER 801 Subpart D) </div> |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <svg height="12" width="12"> <rect fill="none" height="12" stroke="black" width="12"></rect> </svg> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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Image /page/3/Picture/0 description: The image shows the logo for 3D Global Biotech. The logo consists of the number "3" and the letter "D" in green, followed by the words "GLOBAL" and "BIOTECH" stacked on top of each other in gray. The logo is simple and modern, and the colors are eye-catching.

# K191774 - 510(k) Summary

# Applicant:

3D Global Biotech Inc.

Address: 21F-1, No.99, Sec. 1, Xintai 5th Rd., Xizhi Dist., New Taipei City 221, Taiwan

Telephone: [phone]

### Correspondent Contact:

Diana Lam,

DuoCare, LLC

[e-mail]

### Date Summary Prepared:

Semptember 30, 2019

DEVICE NAME: SmileAlign® Orthodontic Aligner System

TRADE NAME: SmileAlign® Orthodontic Aligner System

COMMON NAME: Aligner, Sequential

DEVICE CLASSIFICATION Name: Orthodontic Plastic Bracket

CLASSIFICATION REGULATION NUMBER: 21 CFR 872.5470 DEVICE CLASSIFICATION: CLASS II CLASSIFICATION PRODUCT CODE: NXC

#### Predicate Device

| Primary Predicate | Byte Aligner System | K180346 | Straight Smile, LLC |
|-------------------|-----------------------|---------|---------------------|
| Reference Device | 3Shape Ortho System ™ | K152086 | 3Shape A/S |

#### Description of Device

The SmileAlign® Orthodontic Aligner System is a series of dental aligners fabricated of clear, thin thermoformed polyethylene terephthalate glycol (PETG) plastic to progressively reposition the teeth. Corrective force to straighten the teeth is delivered via minor changes into a modified position in each subsequent aligner.

## Indications for Use

The SmileAlign® Orthodontic Aligner System is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e., all second molars). The SmileAlign® Orthodontic Aligner System positions teeth by way of continuous gentle force.

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Image /page/4/Picture/0 description: The image contains the logo for Global Biotech. The logo has the number 3 in green on the left side of the image. To the right of the number 3 is the text "GLOBAL BIOTECH" in gray.

# Substantial equivalence

The SmileAlign® Orthodontic Aligner System is substantially equivalent to the predicate device with respect to indications for use, technological characteristics, principles of operation and materials...... as demonstrated in the comparison table below.

| Item Name | Subject device | Predicate Device | Substantial<br>equivalence<br>Analysis |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|
| Device name | SmileAlign® Orthodontic<br>Aligner System | Byte Aligner System | - |
| Manufacturer | 3D Global Biotech Inc. | Straight Smile, LLC | - |
| 510(K) No. | - | K180346 | - |
| Regulation<br>No. | 21 CFR 872.5470 | 21 CFR 872.5470 | Same |
| Classification<br>Name | Orthodontic Plastic Bracket | Orthodontic Plastic Bracket | Same |
| Regulatory<br>Class | Class II | Class II | Same |
| Product<br>Code | NXC | NXC | Same |
| Indications<br>for use | The SmileAlign® Orthodontic<br>Aligner System is indicated for<br>the treatment of tooth<br>malocclusion in patients with<br>permanent dentition (i.e., all<br>second molars). The<br>SmileAlign® Orthodontic<br>Aligner System positions teeth<br>by way of continuous gentle<br>force. | The Byte Aligner System is<br>indicated for the treatment<br>of tooth malocclusion in<br>patients with permanent<br>dentition (i.e., all second<br>molars). The Byte Aligner<br>System positions teeth by<br>way of continuous gentle<br>force. | Same |
| Intended<br>Population | Individuals with permanent<br>dentition | Individuals with permanent<br>dentition | Same |
| Mode of<br>Action | Orthodontic tooth movement<br>occurs through forces applied<br>by the device to the dentition<br>as each tooth follows the<br>programmed displacement<br>based on a doctor's<br>prescription. | Orthodontic tooth movement<br>occurs through forces<br>applied by the device to the<br>dentition as each tooth<br>follows the programmed<br>displacement based on a<br>doctor's prescription. | Same |
| Mode of Use | Each aligner is worn by the<br>patient as determined by the<br>treating dental practitioner,<br>generally for 2 weeks prior to<br>being replaced by the next<br>aligner in sequence. This is<br>repeated for a duration as<br>prescribed by a Dental | Each aligner is worn by the<br>patient as determined by the<br>treating dental practitioner,<br>generally for 2 weeks prior<br>to being replaced by the<br>next aligner in sequence.<br>This is<br>repeated for a duration as | Same |
| | | | |
| | Professional. | prescribed by a Dental<br>Professional. | |
| Raw Material<br>Used | Thermoplastic polymers<br>(polyethylene terephthalate<br>glycol or PETG) | Thermoplastic polymers<br>(polyethylene terephthalate<br>glycol or PETG) | Same |
| OTC or Rx | Rx | Rx | Same |
| Design | Image: clear aligner | Image: clear aligner | Same |

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Image /page/5/Picture/0 description: The image shows the logo for 3D Global Biotech. The logo consists of the number "3" and the letter "D" in green, followed by the words "GLOBAL" and "BIOTECH" in gray. The words "GLOBAL" and "BIOTECH" are stacked on top of each other.

The SmileAlign® Orthodontic Aligner System is substantially equivalent to the predicate device. Both the subject and predicate devices use independent dental software to translate tooth movements in developing the model schemes and allow the dental practitioner to review and approve the model schemes before aligner fabrication. The difference between the subject and predicate device lies in the difference in manufacturer, where the risks have been mitigated by biocompatibility evaluation and material testing. SmileAlign® Orthodontic Aligner System uses 3Shape Ortho System™ (K152086), the reference predicate, as the software for dental professionals to generate and review model schemes.

#### Non-Clinical performance Data

Different biocompatibility tests in accordance with ISO10993 have been performed on the subject device. The results of these tests and studies indicate there is no evidence of any hazardous effects and the subject device is safe for its intended use.

| Test Name | Standard followed | Result |
|---------------|-------------------|--------|
| Cytotoxicity | ISO10993-5 | Pass |
| Irritation | ISO10993-10 | Pass |
| Sensitization | ISO10993-10 | Pass |

Material properties, such as tensile strength, compression strength, water absorption rate, density and pH change were tested, all results provided reasonable assurance of safety and effectiveness.

# Clinical performance Data

Clinical data was not included in this submission.

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Image /page/6/Picture/0 description: The image contains the logo for 3D GLOBAL BIOTECH. The logo has the number "3D" in green on the left side of the image. To the right of the number "3D" is the text "GLOBAL BIOTECH" in gray.

www.3dqlobalbiotech.com.tw Tel: [phone] Fax: [phone]

### Conclusion

The SmileAlign® Orthodontic Aligner System has substantially equivalent Indications for Use and technological characteristics to the previously cleared predicate device Byte Aligner System (K180346). The conclusions drawn from the data included in this submission demonstrate that SmileAlign® Orthodontic Aligner System is substantially equivalent to the predicate devices in indications for use, design, technological characteristics, mode of action, method of use, performance, materials, and biocompatibility.