(314 days)
Not Found
No
The description focuses on traditional orthodontic treatment planning software and 3D printing, with no mention of AI or ML algorithms being used for treatment planning, image analysis, or any other function. The "Mentions AI, DNN, or ML" section also explicitly states "Not Found".
Yes
The device is indicated for "orthodontic treatment of misalignment and malocclusion," which is a therapeutic purpose.
No
The device, Illusion Aligners, is an orthodontic treatment device intended for the alignment of teeth. Its function is to gradually move teeth to a desired position, not to diagnose a condition. The diagnostic assessment of the patient's teeth is performed by a dental professional, who then prescribes the aligners.
No
The device description clearly states that the Illusion Aligners Pro and Illusion Aligner Flx are "intraoral thermoplastic appliances" that are "fabricated using a three-step process" involving 3D printing and thermoforming. These are physical components, not solely software. While software is used in the treatment planning process, the final device delivered to the patient is a physical aligner.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The description clearly states that the Illusion Aligners Pro and Illusion Aligner Flx are intraoral thermoplastic appliances that are worn by the patient to physically move teeth. They do not analyze or test any biological samples.
- The intended use is for orthodontic treatment. The purpose is to align teeth through physical force, not to diagnose a condition or provide information about a patient's health based on a biological sample.
- The process involves physical impressions/scans and 3D printing. While these are inputs for creating the device, they are not biological specimens being analyzed for diagnostic purposes.
The device is a medical device used for treatment, specifically orthodontic treatment, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
NXC
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 threestep 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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Oral Cavity
Indicated Patient Age Range
Individuals with permanent dentition
Intended User / Care Setting
Dental health professional (e.g., an orthodontist or a dentist)
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 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.
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.
1
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).
2
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
3
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.
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.
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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.
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
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.
| Comparison
Parameters | Subject Device (Illusion Aligners Pro) | Predicate Device (DailyMate
aligners) |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510K Number | K233356 | K212803 |
| Indication for
Use | The Illusion Aligners Pro is indicated for
use in the alignment of permanent teeth
(i.e., all second molars) through
orthodontic treatment of misalignment
and malocclusion | The DailyMate Orthodontic
Aligner System is indicated for
the treatment of tooth
malocclusion in patients with
permanent dentition. The aligner
system repositions teeth by way
of continuous gentle force. |
| Product Code | NXC | NXC |
| Intended
Population | Individuals with permanent dentition | Individuals with permanent
dentition |
| OTC or Rx | Rx | Rx |
| Raw Material
Used | Polyurethane | Polyurethane |
| Mode of Action | The aligner is an orthodontic appliance
intended for intra-oral use. Individual
devices will be used between 20 - 22
hours per day for a period ranging from
one to three weeks The corrective forces
to align teeth are primarily generated by
the difference between the starting tooth
position and the planned tooth position
defined by the tray. | Based on the clinician's
treatment plan, each aligner is
used for a defined period of time
to exert gentle force to achieve
progressive realignment of the
teeth. This occurs over time until
the final correction has been
achieved. |
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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.
| Comparison
Parameters | Subject Device (Illusion Aligner Flx) | Predicate Device (Smylio Invisible
Clear Aligners) |
|----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510K Number | K233356 | K212660 |
| Indication for
Use | The Illusion Aligner Flx is indicated for use
in the alignment of permanent teeth (i.e.,
all second molars) through orthodontic
treatment of misalignment and
malocclusion | The Smylio Invisible Clear Aligners is
indicated for the alignment of teeth
during orthodontic treatment of
malocclusion. |
| Product Code | NXC | NXC |
| Intended
Population | Individuals with permanent dentition | Individuals with permanent dentition |
| Mode of
Action | Orthodontic tooth movement occurs
through forces applied by the device to the
dentition as each tooth follows the
programmed displacement based on a
doctor's prescription | Orthodontic tooth movement occurs
through forces applied by the device
to the dentition as each tooth follows
the programmed displacement based
on a doctor's prescription |
| OTC or Rx | Rx | Rx |
| Raw Material
Used | Co-polyester and polyurethane composite | Thermoplastic polyurethane polyester
composite resin |
| Anatomical
Site of Use | Oral Cavity | Oral Cavity |
| Mode of
Action
/Operating
Principle | The aligner is an orthodontic appliance
intended for intra-oral use. Individual
devices will be used between 20 – 22 hours
per day for a period ranging from one to
three weeks The corrective forces to align
teeth are primarily generated by the
difference between the starting tooth
position and the planned tooth position
defined by the tray. | Continuous gentle force applied to
teeth following the prescribed and
approved treatment plan to achieve
orthodontic 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.