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

Illusion Aligner Flx are indicated for use in the alignment teeth (i.e. all second molars) through orthodontic treatment of misalignment and malocclusion.

Device Description

A dental health professional (e.g., an orthodontist or a dentist) prescribes the Illusion Aligners Pro and Illusion Aligner Flx are based on an assessment of the patient's teeth. The dental health professional (dentist/orthodontist) takes either the intraoral scans or physical impressions of the patient's teeth, determines the required corrections to align the teeth, and 3Shape's Ortho System is used for treatment planning. Illusion Aligners Pro and Illusion Aligner Flx are intraoral thermoplastic appliances that are worn 20 to 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 Pro and Illusion Aligner Flx are fabricated using a three- step process.

The first step is to obtain the dimensions and details of the patient's dentition. This is generally done using an intraoral scan or a physical impression. This scanned data (digital CAD/CAM models or patient models) is imported into specialized dental software for treatment planning.

The second step is the printing of 3D models of the treatment plan for use in step 3 (thermoforming). In the second step, Illusion Aligners Pro and Illusion Aligner Flx 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. The treatment plan is sent to the doctor for approval. Upon approval, a 3D printer is used to create the models needed for each treatment step to provide the surface around which the aligner is thermoformed.

The final step is the thermoforming of a plastic sheet material to each of the sequential treatment steps. This process is done using standard thermoforming equipment and the appropriate material as specified. The trays are provided to the dental health care professional who provides them to the patient in sequential stages, confirming fit and design. The dental health professional monitors treatment from the moment the first aligner is delivered to when the final aligner is finished, and treatment is complete

AI/ML Overview

The provided text is a 510(k) Summary for the devices Illusion Aligner Pro and Illusion Aligner Flx. It details the safety and effectiveness assessment based on substantial equivalence to predicate devices, rather than a study proving the device meets specific performance criteria.

Therefore, many of the requested details about acceptance criteria, study design (sample size, data provenance, ground truth establishment, expert involvement, adjudication, MRMC studies, standalone performance), and training set information are not present in this document.

The document explicitly states: "No clinical study was conducted." This is a key piece of information that means the device's performance was not evaluated through clinical trials or comparative effectiveness studies described in points 2-7 of your request.

Here's a breakdown of the available information based on your request, highlighting what is not provided:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria: Not explicitly stated as quantifiable performance metrics from a study. The acceptance is based on demonstrating substantial equivalence to predicate devices.
Reported Device Performance: No quantitative performance data is present as no clinical or comparative performance study was conducted. The "performance tests" mentioned are likely non-clinical (e.g., material properties, dimensional accuracy relative to the manufacturing process), but specific metrics are not detailed.

The comparison tables (Table-1 and Table-2) focus on technological characteristics and intended use alignment with predicate devices, not on quantifiable performance metrics of the subject devices themselves.

2. Sample size used for the test set and the data provenance:

Not provided. No test set or data provenance from a performance study is mentioned, as no clinical study was conducted.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable/Not provided. No test set or associated ground truth established by experts is mentioned.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable/Not provided. No test set or adjudication process is mentioned.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No MRMC study was done. This device is an orthodontic aligner, not an AI-assisted diagnostic tool for human readers. The document explicitly states, "No clinical study was conducted."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable/Not provided. This is a physical medical device (aligner), not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable/Not provided. No ground truth for a performance study is mentioned.

8. The sample size for the training set:

Not applicable/Not provided. This document describes a physical medical device (aligner) requiring traditional substantial equivalence demonstration, not a machine learning model that would have a "training set."

9. How the ground truth for the training set was established:

Not applicable/Not provided. As above, this concept does not apply to the type of device and submission described.

Summary of what the document does provide regarding acceptance and proof:

The acceptance criteria and proof of safety and effectiveness for Illusion Aligner Pro and Illusion Aligner Flx derive from demonstrating Substantial Equivalence (SE) to legally marketed predicate devices, as per the FDA 510(k) pathway.

Acceptance Criteria (Implicit via Substantial Equivalence):
- Same Indications for Use: The subject devices align with the predicate devices in their indication for "alignment of permanent teeth (i.e., all second molars) through orthodontic treatment of misalignment and malocclusion."
- Similar Technological Characteristics: The devices share fundamental design principles and mode of action (applying continuous gentle force for tooth movement).
- Equivalent Materials: Illusion Aligner Pro uses polyurethane, matching its predicate DailyMate. Illusion Aligner Flx uses co-polyester and polyurethane composite, matching its predicate Smylio Invisible Clear Aligners.
- Biocompatibility: The devices must meet ISO 10993 standards for permanent tissue-contacting mucosal membrane devices (contact > 30 days).
Study Proving Acceptance (Method of Proof):
- The primary method of proof is comparison to predicate devices and non-clinical testing.
- Biocompatibility Testing: The devices were evaluated for:
  - In Vitro Cytotoxicity (ISO 10993-5:2009)
  - Skin Sensitization (ISO 10993-10:2021)
  - Intracutaneous Reactivity (ISO 10993-23:2021)
- Performance Tests: General statement that "Performance tests were conducted to demonstrate that the subject device is as effective as its predicate device." However, no specific metrics or data from these tests are provided in this summary. These tests likely relate to physical properties and manufacturing quality control rather than clinical outcomes.
- Animal Study: The conclusion mentions "animal study provided in this submission," but no details of such a study are present in the extract provided.
- No Clinical Study: Explicitly stated, "No clinical study was conducted."

In essence, the "proof" is that the new devices are sufficiently similar to already legally marketed devices in terms of materials, intended use, and fundamental mode of action, and they meet relevant non-clinical safety standards (biocompatibility). The FDA assumes that if these similarities hold, the new device is as safe and effective as the predicate.

Summary

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August 8, 2024

Laxmi Dental Export PVT. LTD % Jennifer Day Regulatory Consultant Prime Path Medtech 811 Lakeview Dr. Shoreview, Minnesota 55126

Re: K233356

Trade/Device Name: Illusion Aligner Pro: Illusion Aligner FLX Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: September 29, 2023 Received: September 29, 2023

Dear Jennifer Day:

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 (the 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 available 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).

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Sincerely,

Michael E. Adjodha -S

Michael E. Adjodha, MChE, RAC, CQIA 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) K233356

Device Name Illusion Aligner Pro Illusion Aligner Flx

Indications for Use (Describe)

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

Illusion Aligner Flx are indicated for use in the alignment teeth (i.e. all second molars) through orthodontic treatment of misalignment and malocclusion.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/4/Picture/0 description: The image shows the logo for Laxmi Dental Export PVT. LTD. The logo consists of the letters "LD" in a stylized font. The "L" is in black, and the "D" is in red. To the right of the letters is the company name, "LAXMI DENTAL EXPORT PVT. LTD.", with "LAXMI" in red and the rest of the text in black.

K233356

510(k) Summary

This Traditional 510(k) Summary information is being submitted in accordance with Title 21, CFR Section 807.92.

1. SUBMITTER

Name of Manufacturer/Owner of 510(k):	Laxmi Dental Exports Pvt Ltd
	Survey No. 201/1, Village Gundale, Boisar Chillar
	Highway, Boisar, District – Palghar, India – 401501
FDA Establishment Registration Number:	3004793856
Primary Contact Person:	Samee Merchant
Email Address	sameer@laxmidental.com
Phone Number	022 - 61437900
Fax Number	022 - 61437999
Date of Summary Prepared	7/9/2024

2. PURPOSE OF THIS SUBMISSION

This submission seeks clearance for the Illusion Aligner Pro and Illusion Aligner Flx; they are substantially equivalent to DailyMate Orthodontic Aligner System (K212803) and Smylio Invisible Clear Aligners (K212660), respectively.

3. SUBJECT DEVICES

Device Name: Illusion Aligner Pro

Common Name or Usual Name: Aligner, Sequential

Classification Name: Orthodontic plastic bracket (21 CFR 872.5470)

Regulatory Class: II (21 CFR 872.5470)

Product Code: NXC (21 CFR 872.5470)

Device Name: Illusion Aligner Flx Common Name or Usual Name: Aligner, Sequential Classification Name: Orthodontic plastic bracket (21 CFR 872.5470) Regulatory Class: II (21 CFR 872.5470) Product Code: NXC (21 CFR 872.5470)

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Image /page/5/Picture/0 description: The image shows the logo for Laxmi Dental Export Pvt. Ltd. The logo consists of a stylized letter "L" in black, followed by a stylized letter "D" in red. To the right of the letters, the text "LAXMI DENTAL EXPORT PVT. LTD." is written in a smaller, sans-serif font. The text is arranged in three lines, with "LAXMI" in red and the rest of the text in black.

4. PREDICATE DEVICES

Illusion Aligner Pro – Predicate Devices Predicate Device 510(K) Number: K212803 Predicate Device Name: DailyMate Orthodontic Aligner System Common Name or Usual Name: Aligner, Sequential Classification Name: Orthodontic plastic bracket (21 CFR 872.5470) Regulatory Class: II (21 CFR 872.5470) Product Code: NXC (21 CFR 872.5470) Manufacturer: 3D Global Biotech Inc

Illusion Aligner Flx - Predicate Devices

Predicate Device 510(K) Number: K212660 Predicate Device Name: Smylio Invisible Clear Aligners Common Name or Usual Name: Aligner, Sequential Classification Name: Orthodontic plastic bracket (21 CFR 872.5470) Regulatory Class: II (21 CFR 872.5470) Product Code: NXC (21 CFR 872.5470) Manufacturer: SMYLIO, INC.

INDICATIONS FOR USE ട.

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

DEVICE DESCRIPTION 6.

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Image /page/6/Picture/0 description: The image shows a logo for Laxmi Dental Export PVT. LTD. The logo consists of the letters "L" and "D" in a stylized font. The "L" is in black, and the "D" is in red. To the right of the letters is the text "LAXMI DENTAL EXPORT PVT. LTD." in a smaller font.

TECHNOLOGICAL CHARACTERISTICS 7.

A comparison of the relevant technological characteristics between the subject and primary predicate devices is provided in table-1 that follows.

8. MATERIALS

The Illusion Aligners Pro is made up of polyurethane while Illusion Aligner Flx is made up of copolyester and polyurethane composite. The thickness and weight of the test item is 0.8 mm and 10 grams respectively. The DailyMate aligners are produced from polyurethane. The Smylio Invisible Clear Aligners are produced from co-polyester and polyurethane composite.

9. COMPARISON WITH THE PREDICATE DEVICES

The Illusion Aligners Pro and the predicate device (DailyMate) consist of the same ingredients. They have the same intended use, similar designs, and performance, and meet the biocompatibility requirements.

The Illusion Aligner Flx and the predicate device (Smylio Invisible Clear Aligners) consist of the same ingredients. They have the same intended use, similar designs, and performance, and meet the biocompatibility requirements.

The table below compares the subject device to the predicate and reference devices.

Table-1. Illusion Aligners Pro predicate comparison table.

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Image /page/7/Picture/0 description: The image contains a logo for Laxmi Dental Export PVT. LTD. The logo consists of the letters "LD" in a stylized font, with the "L" in black and the "D" in red. To the right of the letters, the words "LAXMI DENTAL" are written in red, with "EXPORT PVT. LTD." written in black below it.

ComparisonParameters	Subject Device (Illusion Aligners Pro)	Predicate Device (DailyMatealigners)
510K Number	K233356	K212803
Indication forUse	The Illusion Aligners Pro is indicated foruse in the alignment of permanent teeth(i.e., all second molars) throughorthodontic treatment of misalignmentand malocclusion	The DailyMate OrthodonticAligner System is indicated forthe treatment of toothmalocclusion in patients withpermanent dentition. The alignersystem repositions teeth by wayof continuous gentle force.
Product Code	NXC	NXC
IntendedPopulation	Individuals with permanent dentition	Individuals with permanentdentition
OTC or Rx	Rx	Rx
Raw MaterialUsed	Polyurethane	Polyurethane
Mode of Action	The aligner is an orthodontic applianceintended for intra-oral use. Individualdevices will be used between 20 - 22hours per day for a period ranging fromone to three weeks The corrective forcesto align teeth are primarily generated bythe difference between the starting toothposition and the planned tooth positiondefined by the tray.	Based on the clinician'streatment plan, each aligner isused for a defined period of timeto exert gentle force to achieveprogressive realignment of theteeth. This occurs over time untilthe final correction has beenachieved.

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Image /page/8/Picture/0 description: The image shows the logo for Laxmi Dental Export PVT. LTD. The logo consists of the letters "L" and "D" in a stylized font. The "L" is in black, and the "D" is in red. To the right of the letters is the company name, "LAXMI DENTAL EXPORT PVT. LTD.", with "LAXMI" in red and the rest of the text in black.

ComparisonParameters	Subject Device (Illusion Aligner Flx)	Predicate Device (Smylio InvisibleClear Aligners)
510K Number	K233356	K212660
Indication forUse	The Illusion Aligner Flx is indicated for usein the alignment of permanent teeth (i.e.,all second molars) through orthodontictreatment of misalignment andmalocclusion	The Smylio Invisible Clear Aligners isindicated for the alignment of teethduring orthodontic treatment ofmalocclusion.
Product Code	NXC	NXC
IntendedPopulation	Individuals with permanent dentition	Individuals with permanent dentition
Mode ofAction	Orthodontic tooth movement occursthrough forces applied by the device to thedentition as each tooth follows theprogrammed displacement based on adoctor's prescription	Orthodontic tooth movement occursthrough forces applied by the deviceto the dentition as each tooth followsthe programmed displacement basedon a doctor's prescription
OTC or Rx	Rx	Rx
Raw MaterialUsed	Co-polyester and polyurethane composite	Thermoplastic polyurethane polyestercomposite resin
AnatomicalSite of Use	Oral Cavity	Oral Cavity
Mode ofAction/OperatingPrinciple	The aligner is an orthodontic applianceintended for intra-oral use. Individualdevices will be used between 20 – 22 hoursper day for a period ranging from one tothree weeks The corrective forces to alignteeth are primarily generated by thedifference between the starting toothposition and the planned tooth positiondefined by the tray.	Continuous gentle force applied toteeth following the prescribed andapproved treatment plan to achieveorthodontic movement

Table-2. Illusion Aligners Flx predicate comparison table.

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Image /page/9/Picture/0 description: The image shows the logo for Laxmi Dental Export PVT. LTD. The logo consists of a stylized letter "L" in black, followed by a red shape resembling a "D". To the right of these shapes, the text "LAXMI DENTAL EXPORT PVT. LTD." is displayed in a simple, sans-serif font.

10. SUBSTANTIAL EQUIVALENCE DISCUSSION

Illusion Aligners Pro and Illusion Aligner Flx have been subjected to ISO 10993 biocompatibility studies to demonstrate the device is as safe as its predicate device. The performance tests were conducted to demonstrate that the subject device is as effective as its predicate device.

Biocompatibility Testing

Per ISO 10993-1: 2018, Illusion Aligner Pro and Illusion Aligner Flx direct tissue-contacting, surface device contacting mucosal membrane for > 30 days due to treatment consisting of multiple aligners worn for 7 days consecutively. Thus, the aligners are permanent tissue contacting devices.

The subject device was evaluated for:

In Vitro Cytotoxicity (ISO 10993-5:2009) Skin Sensitization (ISO 10993-10: 2021) Intracutaneous Reactivity (ISO 10993-23:2021)

Clinical Studies

No clinical study was conducted.

11. CONCLUSIONS

Based on the comparison analysis, performance tests, biocompatibility tests and animal study provided in this submission, the subject device, Illusion Aligners Pro and Illusion Aligner Flx are demonstrated to be as safe and effective as the legally marketed predicate device,

DailyMate aligners and Smylio Invisible Clear Aligners. So, the subject devices are considered Substantially Equivalent (SE) to the predicate devices.

Regulation Number and Section

§ 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.