(21 days)
No
The description focuses on a standard digital workflow for creating aligners, including scanning, software-based treatment planning, 3D printing, and thermoforming. There is no mention of AI or ML being used in the treatment planning software or any other part of the process.
Yes
The device, Illusion Aligners, is described as aligning permanent teeth through orthodontic treatment of misalignment and malocclusion, fitting the definition of a therapeutic device.
No
The device, Illusion Aligners, is described as an orthodontic treatment for the alignment of teeth. It is used to gradually move teeth to a desired position, which is a therapeutic rather than a diagnostic function. While it uses an "oral scan data or a physical impression" to obtain dimensions, this input is for planning the treatment (creating sequential models for aligner fabrication) and not for diagnosing a medical condition.
No
The device description clearly states that the Illusion Aligners are "intraoral thermoformed plastic aligners" and describes a manufacturing process involving 3D printing and thermoforming, indicating a physical hardware component. While software is used in the treatment planning, the final device is a physical aligner.
Based on the provided information, the Illusion Aligners are not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The Illusion Aligners are physical devices worn inside the mouth to apply force to teeth. They do not analyze or test any biological samples.
- The intended use is for orthodontic treatment of misalignment and malocclusion. This is a therapeutic purpose, not a diagnostic one.
- The device description focuses on the fabrication and function of the aligners themselves. It describes a manufacturing process and how the aligners physically interact with teeth.
- The performance studies mentioned are biocompatibility and physical properties testing. These are relevant for a medical device that comes into contact with the body, but not for an IVD which would typically involve analytical performance studies.
The information clearly indicates that the Illusion Aligners are a medical device used for orthodontic treatment, not an IVD used for diagnostic purposes.
N/A
Intended Use / Indications for 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.
Product codes
NXC
Device Description
Illusion Aligners are intraoral thermoformed plastic aligners that are worn at least 22 hours per day and are designed to be used in a sequence, each aligner providing a gentle continuous force, to allow for the movement of teeth to the final desired position. The aligners are to be removed for eating and for cleaning. Illusion Aligners are fabricated using a ten-step process.
The Step 1 is to obtain the dimensions and details of the patient's baseline dentition. This is generally done using an oral scan data or a physical impression. Step 3, the scanned data (digital CAD/CAM models or patient models) are imported into specialized dental software for treatment planning. In the Step 3, Laxmi Dental Exports Pvt Ltd, Inc. utilizes a software application to plan the treatment by creating a series of sequential models that gradually position the teeth into their final desired position. Step 4, the treatment plan is sent to the doctor for approval. Upon approval, a 3D printer is used to create the molds needed for each treatment step to provide the surface around which the aligner is thermoformed. Step 5 is the printing of 3D models of the treatment plan for use in Step 7 thermoforming. The thermoforming process is accomplished using a standard thermoforming equipment and the appropriate material as outlined in this submission.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
oral scan data or a physical impression
Anatomical Site
permanent teeth (i.e. all second molars)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental practitioner
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Device Testing:
Biocompatibility
Contact of the device to the patient's oral tissue requires the Aligners material to be biocompatible. The thermoplastic PETG (Polyethylene terephthalate glycol) material has been tested according to Good Laboratory Practices for its biocompatibility according to ISO 10993, as follows:
Part 5 (Cytotoxicity Elution - MEM)
Part 10 (Skin Irritation)
Part 10 (Guinea Pig Maximization Test)
Animal Human Testing
No human testing is required for this product because it is composed of the same materials and has a similar design and method of manufacture/fabrication in comparison to the predicate device.
Non-Clinical Physical Properties Testing:
Device material tested to the following standards and meet the acceptance criteria
• Elongation @ Yield (%) ASTM D638
• Elongation @ Break (%) ASTM D638
• Tensile @ Yield (PSI) ASTM D638
• Tensile Strength (PSI) ASTM D638
• Tensile Modulus (PSI) ASTM D638
• Water Absorption (%)24 hours @ 23°C ASTM D570
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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.
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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, |
| 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 | |
| Number | |
| Product Code | |
| Regulatory Class | Orthodontic Plastic Bracket |
| 21 CFR 872.5470 | |
| NXC | |
| 2 | |
| Primary Predicate | |
| Device: | K173784, Smylio Invisible Clear Aligner |
| Statement of | |
| Indications | |
| for 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 Description | |
| and Summary of | |
| Technological | |
| Characteristics | Illusion Aligners are intraoral thermoformed plastic aligners that are |
| worn at least 22 hours per day and are designed to be used in a | |
| sequence, each aligner providing a gentle continuous force, to | |
| allow for the movement of teeth to the final desired position. The | |
| aligners are to be removed for eating and for cleaning. Illusion | |
| Aligners are fabricated using a ten-step process. |
The Step 1 is to obtain the dimensions and details of the patient's
baseline dentition. This is generally done using an oral scan data or
a physical impression. Step 3, the scanned data (digital CAD/CAM
models or patient models) are imported into specialized dental
software for treatment planning. In the Step 3, Laxmi Dental
Exports Pvt Ltd, Inc. utilizes a software application to plan the
treatment by creating a series of sequential models that gradually
position the teeth into their final desired position. Step 4, the
treatment plan is sent to the doctor for approval. Upon approval, a
3D printer is used to create the molds needed for each treatment
step to provide the surface around which the aligner is
thermoformed. Step 5 is the printing of 3D models of the treatment
plan for use in Step 7 thermoforming. The thermoforming process
is accomplished using a standard thermoforming equipment and
the appropriate material as outlined in this submission. |
| Mechanism of Action | In the same manner as the predicate device, each aligner
exerts gentle force to achieve progressive realignment of the
teeth until the final correction has been attained. This is based
on the treatment plan and proceeds over time. |
| Device Testing | Biocompatibility
Contact of the device to the patient's oral tissue requires the
Aligners material to be biocompatible. The thermoplastic PETG
(Polyethylene terephthalate glycol) material has been tested
according to Good Laboratory Practices for its biocompatibility
according to ISO 10993, as follows:
Part 5 (Cytotoxicity Elution - MEM)
Part 10 (Skin Irritation)
Part 10 (Guinea Pig Maximization Test) |
| | Animal Human Testing
No human testing is required for this product because it is
composed of the same materials and has a similar design and
method of manufacture/fabrication in comparison to the
predicate device. |
| Non-Clinical Physical
Properties Testing: | Device material tested to the following standards and meet the acceptance
criteria
• Elongation @ Yield (%) ASTM D638
• Elongation @ Break (%) ASTM D638
• Tensile @ Yield (PSI) ASTM D638
• Tensile Strength (PSI) ASTM D638
• Tensile Modulus (PSI) ASTM D638
• Water Absorption (%)24 hours @ 23°C ASTM D570 |
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| Trade Name: | Submission Device | Predicate Device |
|---|---|---|
| Illusion Aligners | K173784 | |
| Smylio Invisible Clear Aligners | ||
| 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 | |
| alignment of permanent teeth (i.e. all second | ||
| molars) through orthodontic treatment of | ||
| misalignment and malocclusion. | Smylio Invisible Clear Aligners is indicated | |
| for use in the alignment of permanent | ||
| teeth through orthodontic treatment of | ||
| misalignment and malocclusion. | ||
| Mode of Action | Alignment of teeth by application of | |
| continuous gentle force, by sequential use | ||
| of preformed plastic trays. | Alignment of teeth by application of | |
| continuous gentle force, by sequential use | ||
| of preformed plastic trays. | ||
| Method of Use | Each preformed plastic tray is worn by | |
| the patient as prescribed by the dental | ||
| practitioner, usually a few weeks prior to | ||
| using the next sequential Aligners tray. | Each preformed plastic tray is worn | |
| by the patient as prescribed by the | ||
| dental practitioner, usually a few | ||
| weeks prior to using the next | ||
| sequential Aligners tray. | ||
| Material | PETG (Polyethylene | |
| terephthalate glycol) Material | Thin thermoformed | |
| 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 | ||
| the treatment plan in Step 2 of the | ||
| manufacturing process for subsequent | ||
| approval by a doctor. | No effect, both treatment | |
| plans are doctor approved. | Smylio K173784 doctor | |
| prepares the treatment | ||
| plan | ||
| Laxmi Dental Exports Pvt Ltd, Inc. uses | ||
| 3Shape Software K180491 and | ||
| K152086 | No effect, 3Shape Software | |
| K180491 and K152086 are | ||
| FDA 510K cleared, the | ||
| use/manufacturing process | ||
| has been validated by | ||
| Laxmi | Smylio uses 3Shape | |
| Software K152086 | ||
| Laxmi uses PETG (Polyethylene | ||
| terephthalate glycol) thermoforming | ||
| material for the aligner | No effect, PETG | |
| (Polyethylene | ||
| terephthalate glycol) | ||
| material is manufacturing | ||
| validated and | ||
| biocompatible. | Smylio Uses Zendura | |
| polyurethane |
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| Laxmi Dental Exports Pvt Ltd, Inc. | No effect on | Smylio biocompatibility |
|---|---|---|
| biocompatibility summary applied ISO | ||
| 10993 | biocompatibility. ISO 7405 | |
| directly references the | summary references ISO | |
| 7405, Dentistry – | ||
| • -5, Biological evaluation of medical | ||
| devices – Part 5: Tests for in vitro | ||
| cytotoxicity | ||
| • -10, Biological evaluation of medical | ||
| devices -- Part 10: Tests for irritation | ||
| and skin sensitization | same test as conducted | |
| using ISO 10993 et.al. | Evaluation of | |
| biocompatibility of | ||
| medical devices used in | ||
| 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.