Illusion Aligners

K211010 · Laxmi Dental Exports Pvt, Ltd. · NXC · Apr 26, 2021 · Dental

Device Facts

• Record ID: K211010
• Device Name: Illusion Aligners
• Applicant: Laxmi Dental Exports Pvt, Ltd.
• Product Code: NXC · Dental
• Decision Date: Apr 26, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5470
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The Illusion Aligners indicated for use in the alignment of permanent teeth (i.e. all second molars) through orthodontic treatment of misalignment and malocclusion.

Device Story

Illusion Aligners are intraoral thermoformed PETG plastic trays used for orthodontic tooth movement. Process: 1) Obtain patient dentition via oral scan or physical impression; 2) Import data into dental CAD/CAM software to plan sequential tooth movement; 3) Doctor reviews and approves treatment plan; 4) 3D print models of each treatment step; 5) Thermoform PETG aligners over 3D-printed models. Aligners are worn by the patient at least 22 hours/day, removed for eating/cleaning. Each tray exerts gentle, continuous force to move teeth toward the final position defined in the plan. Used in clinical settings under the direction of a dental practitioner. Benefits include progressive correction of malocclusion.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing, including biocompatibility (ISO 10993-5, ISO 10993-10) and physical property testing (ASTM D638, ASTM D570).

Technological Characteristics

Material: PETG (Polyethylene terephthalate glycol). Physical properties tested per ASTM D638 (tensile/elongation) and ASTM D570 (water absorption). Manufacturing: 3D printing of models followed by thermoforming. Software: 3Shape CAD/CAM for treatment planning. Biocompatibility: ISO 10993 compliant.

Indications for Use

Indicated for alignment of permanent teeth (including second molars) in patients requiring orthodontic treatment for misalignment and malocclusion.

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

• Smylio Invisible Clear Aligner (K173784)

Reference Devices

• 3Shape Software (K180491)
• 3Shape Software (K152086)

Submission Summary (Full Text)

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April 26, 2021

Laxmi Dental Exports Pvt Ltd % Rafael Aguila Responsible Third-Party Official Accelerated Device Approval Services 6800 S.W. 40th Street, Ste. 403 Ludlum, Florida 33155

Re: K211010

Trade/Device Name: Illusion Aligners Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic plastic bracket Regulatory Class: Class II Product Code: NXC Dated: April 3, 2021 Received: April 5, 2021

Dear Rafael Aguila:

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 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) K211010

Device Name Illusion Aligners

Indications for Use (Describe)

The Illusion Aligners indicated for use in the alignment of permanent teeth (i.e. all second molars) through orthodontic treatment of misalignment and 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)

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## K211010

# 510(k) Summary

| Submitter Name: | Laxmi Dental Exports Pvt Ltd. |
|--------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Address: | Survey No. 201/1, Village Gundale, Boisar Chillar Highway, Boisar, District - Palghar,<br>India - 401501 |
| Phone Number: | 0091 9820268438 |
| Contact Person: | Sameerl Merchant |
| Date Prepared: | November 04,2020 |
| Device Trade Name: | Illusion Aligners |
| Common Name | Aligner, Sequential |
| Classification Name<br>Number<br>Product Code<br>Regulatory Class | Orthodontic Plastic Bracket<br>21 CFR 872.5470<br>NXC<br>2 |
| Primary Predicate<br>Device: | K173784, Smylio Invisible Clear Aligner |
| Statement of<br>Indications<br>for Use | The Illusion Aligners indicated for use in the alignment of permanent<br>teeth (i.e. all second molars) through orthodontic treatment of<br>misalignment and malocclusion. |
| Device Description<br>and Summary of<br>Technological<br>Characteristics | Illusion Aligners are intraoral thermoformed plastic aligners that are<br>worn at least 22 hours per day and are designed to be used in a<br>sequence, each aligner providing a gentle continuous force, to<br>allow for the movement of teeth to the final desired position. The<br>aligners are to be removed for eating and for cleaning. Illusion<br>Aligners are fabricated using a ten-step process.<br><br>The Step 1 is to obtain the dimensions and details of the patient's<br>baseline dentition. This is generally done using an oral scan data or<br>a physical impression. Step 3, the scanned data (digital CAD/CAM<br>models or patient models) are imported into specialized dental<br>software for treatment planning. In the Step 3, Laxmi Dental<br>Exports Pvt Ltd, Inc. utilizes a software application to plan the<br>treatment by creating a series of sequential models that gradually<br>position the teeth into their final desired position. Step 4, the<br>treatment plan is sent to the doctor for approval. Upon approval, a<br>3D printer is used to create the molds needed for each treatment<br>step to provide the surface around which the aligner is<br>thermoformed. Step 5 is the printing of 3D models of the treatment<br>plan for use in Step 7 thermoforming. The thermoforming process<br>is accomplished using a standard thermoforming equipment and<br>the appropriate material as outlined in this submission. |
| Mechanism of Action | In the same manner as the predicate device, each aligner<br>exerts gentle force to achieve progressive realignment of the<br>teeth until the final correction has been attained. This is based<br>on the treatment plan and proceeds over time. |
| Device Testing | Biocompatibility<br>Contact of the device to the patient's oral tissue requires the<br>Aligners material to be biocompatible. The thermoplastic PETG<br>(Polyethylene terephthalate glycol) material has been tested<br>according to Good Laboratory Practices for its biocompatibility<br>according to ISO 10993, as follows:<br>Part 5 (Cytotoxicity Elution - MEM)<br>Part 10 (Skin Irritation)<br>Part 10 (Guinea Pig Maximization Test) |
| | Animal Human Testing<br>No human testing is required for this product because it is<br>composed of the same materials and has a similar design and<br>method of manufacture/fabrication in comparison to the<br>predicate device. |
| Non-Clinical Physical<br>Properties Testing: | Device material tested to the following standards and meet the acceptance<br>criteria<br>• Elongation @ Yield (%) ASTM D638<br>• Elongation @ Break (%) ASTM D638<br>• Tensile @ Yield (PSI) ASTM D638<br>• Tensile Strength (PSI) ASTM D638<br>• Tensile Modulus (PSI) ASTM D638<br>• Water Absorption (%)24 hours @ 23°C ASTM D570 |

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| Trade Name: | Submission Device | Predicate Device |
|-------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Illusion Aligners | K173784<br>Smylio Invisible Clear Aligners<br>K173785 |
| 510(k) Number | | |
| Manufacturer | Laxmi Dental Exports Pvt Ltd | Smylio |
| Classification #, | 21 CFR 852.5470 | 21 CFR 852.5470 |
| Product Code | NXC | NXC |
| Device Class | 2 | 2 |
| Intended Use | The Illusion Aligners indicated for use in the<br>alignment of permanent teeth (i.e. all second<br>molars) through orthodontic treatment of<br>misalignment and malocclusion. | Smylio Invisible Clear Aligners is indicated<br>for use in the alignment of permanent<br>teeth through orthodontic treatment of<br>misalignment and malocclusion. |
| Mode of Action | Alignment of teeth by application of<br>continuous gentle force, by sequential use<br>of preformed plastic trays. | Alignment of teeth by application of<br>continuous gentle force, by sequential use<br>of preformed plastic trays. |
| Method of Use | Each preformed plastic tray is worn by<br>the patient as prescribed by the dental<br>practitioner, usually a few weeks prior to<br>using the next sequential Aligners tray. | Each preformed plastic tray is worn<br>by the patient as prescribed by the<br>dental practitioner, usually a few<br>weeks prior to using the next<br>sequential Aligners tray. |
| Material | PETG (Polyethylene<br>terephthalate glycol) Material | Thin thermoformed<br>polyurethane |
| Biocompatible | Yes | Yes |
| OTC or Rx | Rx | Rx |
| Software Use | Yes | Yes |
| Sterile | No | No |

Differences between Illusion Aligners compared to predicate device

| Illusion Aligners | S & E Effect | Smylio K173784 |
|------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|
| Laxmi Dental Exports Pvt Ltd. prepares<br>the treatment plan in Step 2 of the<br>manufacturing process for subsequent<br>approval by a doctor. | No effect, both treatment<br>plans are doctor approved. | Smylio K173784 doctor<br>prepares the treatment<br>plan |
| Laxmi Dental Exports Pvt Ltd, Inc. uses<br>3Shape Software K180491 and<br>K152086 | No effect, 3Shape Software<br>K180491 and K152086 are<br>FDA 510K cleared, the<br>use/manufacturing process<br>has been validated by<br>Laxmi | Smylio uses 3Shape<br>Software K152086 |
| Laxmi uses PETG (Polyethylene<br>terephthalate glycol) thermoforming<br>material for the aligner | No effect, PETG<br>(Polyethylene<br>terephthalate glycol)<br>material is manufacturing<br>validated and<br>biocompatible. | Smylio Uses Zendura<br>polyurethane |

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| Laxmi Dental Exports Pvt Ltd, Inc. | No effect on | Smylio biocompatibility |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|------------------------------------------------------------------------------|
| biocompatibility summary applied ISO<br>10993 | biocompatibility. ISO 7405<br>directly references the | summary references ISO<br>7405, Dentistry – |
| • -5, Biological evaluation of medical<br>devices – Part 5: Tests for in vitro<br>cytotoxicity<br>• -10, Biological evaluation of medical<br>devices -- Part 10: Tests for irritation<br>and skin sensitization | same test as conducted<br>using ISO 10993 et.al. | Evaluation of<br>biocompatibility of<br>medical devices used in<br>dentistry |

The intended use of the Illusion Aligners is the same to that of the primary predicate device as they are both intended for correcting dental malocclusion in patients with permanent dentition. It has a similar technological principle, and the device characteristics are similar to the predicate device. The mode of operation and the manufacturing process used to fabricate the aligner trays is the same as the predicate device. There are minor differences comparing Illusion Aligners to the predicate Smylio Invisible Clear Aligners which do not affect substantial equivalence or safety and effectiveness.

### Substantial Equivalence Conclusion

Thus, based on the above it can be concluded that Illusion Aligners is substantially equivalent to the predicate device.