iSMILE

K200908 · 3D Diagnostix, Inc. · NXC · Dec 22, 2020 · Dental

Device Facts

• Record ID: K200908
• Device Name: iSMILE
• Applicant: 3D Diagnostix, Inc.
• Product Code: NXC · Dental
• Decision Date: Dec 22, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5470
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

iSMILE is indicated for the alignment of teeth during orthodontic treatment of malocclusion.

Device Story

iSMILE is a series of transparent, patient-specific thermoformed polyurethane aligners; used for orthodontic treatment of malocclusion. Dental professionals create a digital treatment plan; aligners are fabricated via thermoforming. Aligners incorporate attachments to create force points; provide continuous gentle force to move teeth incrementally. Used in clinical settings; prescribed by dental professionals. Patients wear aligners to achieve planned tooth movement. Benefits include improved dental alignment through non-invasive, removable appliance therapy.

Clinical Evidence

Bench testing only. Biocompatibility testing per ISO 10993-1 (cytotoxicity, sensitization, irritation, acute systemic toxicity, mutagenicity, subacute toxicity) passed. Mechanical testing of base materials (tensile strength, elongation, tensile stress at break, modulus, load) and finished aligners (water absorption) showed acceptable results. Process flow validation confirmed finished devices match software output specifications.

Technological Characteristics

Thermoformed transparent polyurethane plastic aligners. Patient-specific dimensions. Mechanism: continuous gentle force via attachments and force points. Biocompatibility per ISO 10993-1. Mechanical properties: tensile strength, elasticity, ductility, chemical resistance. Software-driven digital treatment planning workflow.

Indications for Use

Indicated for the alignment of teeth during orthodontic treatment of malocclusion in patients requiring minor tooth movement.

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

• Invisalign System (K081960)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains 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, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font below.

December 22, 2020

3D Diagnostix Inc. Ehab Amin Ouality and Regulatory Consultant 24 Denby Road Allston, Massachusetts 02134

Re: K200908

Trade/Device Name: iSMILE Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: November 27, 2020 Received: November 27, 2020

Dear Ehab Amin:

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

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Michael E. Adjodha, M.ChE. Assistant 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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Image /page/2/Picture/0 description: The image shows the logo for 3D Diagnostix. The logo has the text "3D Diagnostix" with ".COM" underneath the word Diagnostix. The "3D" is in blue, and the "Diagnostix" is in orange. There is a vertical line separating the "3D" from the word "Diagnostix".

## iSMILE Dental Aligners 510K Traditional File

| DEPARTMENT OF HEALTH AND HUMAN SERVICES |
|-----------------------------------------|
| Food and Drug Administration |
| Indications for Use |

Form Approved: OMB 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page

510(k) Number (if known) K200908

Device Name

iSMILE

Indications for Use (Describe)

iSMILE is indicated for the alignment of teeth during orthodontic treatment of malocclusion.

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)

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

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iSMILE Dental Aligners 510K Additional Information

#### 510(k) SUMMARY

3D Diagnostix Inc.'s iSMILE

#### 510K Number: K200908

Submitter's Name, Address, Telephone Number, Contact Person

and Date Prepared

[COMPANY'S NAME AND ADDRESS]

3D Diagnostix Inc

24 Denby Road

Allston, MA 02134

USA

Phone: [phone]

Fax: [phone]

Contact Person: Ehab Mahmoud

Date Prepared: November 23, 2020

#### Name of Device and Name/Address of Sponsor

| Name of Device: | iSMILE |
|-----------------------|----------------------------------------------------------------------|
| Common or Usual Name: | Dental Plastic Aligners |
| Classification Name: | Orthodontic Plastic Brackets – Sequential Aligners (21 CFR 892.5470) |
| Regulatory Class: | II |
| Product Code: | NXC |

#### Primary Predicate Devices

Invisalign System

K081960

Align Technology, Inc.

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Image /page/4/Picture/0 description: The image shows the logo for 3D Diagnostix. The logo is split into two parts by a vertical line. On the left side of the line is the text "3D" in a blue sans-serif font. On the right side of the line is the text "Diagnostix" in an orange sans-serif font, with ".COM" in a smaller font below the word "Diagnostix".

#### iSMILE Dental Aligners 510K Additional Information

## Intended Use / Indications for Use

The i5MLE is indicated for use in alignment of teeth during orthodontic treatment of malocclusion.

## Technological Characteristics

The iSMILE Aligners that are produced have the same technological characteristics as the primary predicate device, in that all the devices are made from commercially available plastic that is thermoformed to create a customized, patient-specific aligners are then used for minor tooth movement by way of continuous gentle force.

In both devices, the aligners are created by thermoforming commercially available plastic material. The iSMILE Aligners are thermoformed by 3D Diagnostix Inc. and in the case of the primary predicate device; the aligners are thermoformed by an outside laboratory.

The iSMILE Aligner incorporates the use of attachments to create spaces and force points in order to cause minor tooth movement. These force points are located in specific areas and positioned in such a way that they provide a continuous force which slowly dissipates over time on the tooth to be moved for as long as the aligner is worn.

#### Performance Data

As part of demonstrating substantial equivalence of iSMILE to the primary predicate device that are subject to this 510(k) submission, 3D Diagnostix Inc. completed a number of non-clinical performance tests. iSMILE meets all the requirements for overall design, biocompatibility, and performance results confirming that the design output meets the design inputs and specifications for the device.

iSMILE passed all the testing in accordance with internal requirements, national standards, and international standards shown below to support substantial equivalence of the subject device:

- Biocompatibility testing per ISO 10993-1 passed cytotoxicity, sensitization, irritation, Acute Systemic Toxicity, Mutagenicity, and Subacute Toxicity for the used thermoforming sheets.
- There is no defined specification or standard for tensile strength so a sample of base materials used for fabrication of aligners were tested and analyzed producing acceptable results for tensile strength yield.

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## iSMILE Dental Aligners 510K Additional Information

- There is no defined specification or standard for aligner elongation which a sample of based materials used for fabrication of aligners were tested and analyzed showing acceptable results in comparison of break point.
- There is no defined specification or standard for tensile stress so a sample of base materials used for fabrication of aligners were tested and analyzed producing acceptable results for tensile stress at break point.
- There is no defined specification or standard for modulus so this was tested for the base materials used for fabrication of aligners to show acceptable results between the samples tested.
- . There is no defined specification or standard for load of materials which found acceptable results when tested and analyzed for samples of base material tested used for fabrication of aligners.
- . There is no defined specification or standard for water absorption which found acceptable results when tested and analyzed for fabricated aligners.
- Process Flow validation was performed to ensure that the finished device matches the software output specifications. The output and work model and aligner were tested and compared. Aligners met the acceptance criteria of this testing.

In all instances, the iSMILE functioned as intended and Biocompatibility Testing, and Process Flow Validation observed was as expected.

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# Substantial Equivalence

| Feature | Proposed Device<br>iSMILE | Primary Predicate Device<br>Invisalign System |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K Number | K200908 | K081960 |
| Manufacturer | 3D Diganostix Inc. | Align Technology, Inc. |
| Regulation<br>Number | 21 CFR 872.5470 | 21 CFR 872.5470 |
| Device<br>Classification<br>Name | Orthodontic Plastic Bracket | Orthodontic Plastic Bracket |
| Product Code | NXC | NXC |
| Device Class | Class II | Class II |
| Indications for<br>Use | iSMILE is indicated for the alignment of<br>teeth during orthodontic treatment of<br>malocclusion. | The Invisalign System is indicated for<br>the alignment of teeth during<br>orthodontic treatment of<br>malocclusion. |
| Device Description | The iSMILE is a sequence of<br>transparent aligners created from a<br>digital orthodontic treatment plan.<br>The iSMILE aligner is fabricated of a<br>transparent thermoformed<br>polyurethane plastic. Each aligner<br>delivery a unique combination of<br>minor forces to create the planned<br>tooth movement.<br>The digital orthodontic treatment plan<br>is created by a dental health<br>professional.<br>The iSMILE Aligner incorporates the<br>use of attachments to create spaces<br>and force points in order to cause<br>minor tooth movement. These force<br>points are located in specific areas<br>and positioned in such a way that | The current Invisalign system is a<br>series of clear plastic aligners that are<br>used to replace traditional orthodontic<br>wires and brackets for the alignment<br>of maloccluded or misaligned teeth.<br>This series of aligners moves the teeth<br>gently, and in small increments, from<br>their original to their final treated<br>position for improved dental<br>alignment. |

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| 3D Diagnostix<br>· COM | 3D Diagnostix Inc. |
|------------------------|----------------------------------------------------|
| | iSMILE Dental Aligners 510K Additional Information |

| Feature | Proposed Device<br>iSMILE | Primary Predicate Device<br>Invisalign System |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K Number | K200908 | K081960 |
| | they provide a continuous force<br>which slowly dissipates over time on<br>the tooth to be moved for as long as<br>the aligner is worn. | |
| Mode of<br>Action | Orthodontic tooth<br>movement occurs through<br>forces applied by the<br>appliance to the dentition<br>as each tooth follows the<br>programmed displacement<br>based on a doctor's<br>prescription | Orthodontic tooth<br>movement occurs through<br>forces applied by the<br>appliance to the dentition<br>as each tooth follows the<br>programmed displacement<br>based on a doctor's<br>prescription |
| Anatomy Location | Mouth; mucosal | Mouth; mucosal |
| Size | Patient specific | Patient specific |
| Manufacturing<br>Method | Thermoforming | Thermoforming |
| Material | Thermoplastic Polymer | Thermoplastic Polymer |
| Material<br>Properties | Demonstrates sufficient<br>tensile strength, elasticity,<br>ductility, chemical resistance,<br>and clarity for use as a clear<br>tray aligner. | Demonstrates sufficient<br>tensile strength, elasticity,<br>ductility, chemical resistance,<br>and clarity for use as a clear<br>tray aligner. |
| Software Used<br>for Ordering<br>Workflow | Yes | Yes |

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| Image: 3D Diagnostix Logo | 3D Diagnostix Inc. |
|---------------------------|----------------------------------------------------|
| | iSMILE Dental Aligners 510K Additional Information |

| Feature | Proposed Device<br>iSMILE | Primary Predicate Device<br>Invisalign System |
|----------|---------------------------|-----------------------------------------------|
| K Number | K200908 | K081960 |
| Design | Image: iSMILE aligner | Image: Invisalign aligner |

iSMILE has the same intended uses and similar indications, technological characteristics, Manufacturing Method, Material Used and principles of operation as its primary predicate device. iSMILE is substantial equivalent to the Invisalign System.

There are no differences between iSMILE and Invisalign System was defined therefore a performance testing was performed to iSMILE to ensure that patients are receiving the aligners as prescribed by the practitioner to move their teeth as intended (final position). The results of this performance testing are accepted according to acceptance criteria and do not raise any additional concerns.

## Conclusions

iSMILE Aligners moves teeth by way of continuous gentle force through a sequence of clear aligners that follow the treatment plan developed by the clinician as does the primary predicate device, Invisalign System.

The conclusions drawn from the data included in this submission, demonstrates that the iSMILE Aligner is substantially equivalent to the primary predicate devices cleared under premarket notification K081960 (Primary Predicate Device) in indications for use, design, technological characteristics, mechanism of action, performance, materials and biocompatibility.