(253 days)
No
The description details a software application used for treatment planning and creating sequential models, but it does not mention the use of AI or ML algorithms for this process. The software appears to be a standard CAD/CAM type tool for manipulating digital models based on user input.
Yes.
The device is used for the orthodontic treatment of misalignment and malocclusion of permanent teeth, which is a therapeutic purpose.
No
The device description indicates that the Smylio Invisible Clear Aligners are for orthodontic treatment (alignment of teeth) by providing continuous force, which is a therapeutic function, not a diagnostic one. The preliminary steps involve obtaining patient data (oral scan or impression) and treatment planning, but these are for fabricating the aligners, not for diagnosing a condition.
No
The device description clearly states that the device is "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 and manufacturing process, the final device is a physical object.
Based on the provided information, the Smylio Invisible Clear Aligners are not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Smylio's Function: The Smylio Invisible Clear Aligners are a physical device worn in the mouth to apply force to teeth for orthodontic treatment. They are not used to analyze biological specimens.
- Intended Use: The intended use is "alignment of permanent teeth through orthodontic treatment of misalignment and malocclusion," which is a mechanical/physical intervention, not a diagnostic test.
- Device Description: The description details the fabrication process and how the aligners work to move teeth, not how they analyze biological samples.
- Input: The input is oral scan data or physical impressions, which represent the physical structure of the teeth, not biological specimens.
Therefore, the Smylio Invisible Clear Aligners fall under the category of a medical device used for treatment, not an IVD device used for diagnosis.
N/A
Intended Use / Indications for Use
The Smylio Invisible Clear Aligners is indicated for use in the alignment of permanent teeth through orthodontic treatment of misalignment and malocclusion.
Product codes
NXC
Device Description
The Smylio Invisible Clear Aligners are intraoral thermoformed plastic aligners 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.
Smylio Invisible Clear Aligners are fabricated using a three-step process.
The first step 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. This scanned data (digital CAD/CAM models or patient models) are 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, the doctor 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. A 3D printer is used to create the molds 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 a standard thermoforming equipment and the appropriate material as outlined in this submission.
Software Description: Specialized orthodontic CAD/CAM software will be used to develop the treatment plans and to produce standard 3D printer files that will facilitate the manufacturing of each sequential aligner in the treatment plan. The software application used for the manufacturing validation in this submission is the 3Shape®.
Material: The material used for the manufacturing validation in this submission is the Zendura®.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
oral scan data or a physical impression
Anatomical Site
Teeth (permanent dentition)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Manufacturing Validation:
- Study type: Dimensional accuracy assessment of manufacturing process.
- Sample size: Not specified.
- Key results: All translational measurements were within 0.3 mm of the target input value and all rotational measurements were within 3° of the target input value, the predefined tolerance of the manufacturing process. There were no statistical differences in the intended and measured values observed from any of the groups. This test has met the pre-established acceptance criteria to demonstrate dimensional accuracy.
Biocompatibility Assessment:
- Study type: Biocompatibility assessment, compliant with ISO 7405:2008.
- Sample size: Not specified.
- Key results: Tested and shown to be compliant with ISO 7405:2008 Dentistry Evaluation of biocompatibility of medical devices used in dentistry.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Derby Dental Laboratory Custom Clear Aligner System (K173785)
Reference Device(s)
3Shape OrthoSystem™ Software (K152086), ClearCorrect System (K113618)
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.
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 23, 2018
Smylio, Inc % Mr. Bill Jacqmein Regulatory Affairs Consultant JCQ Consulting 11218 Zest Court NE Blaine, Minnesota 55449
Re: K173784
Trade/Device Name: Smylio Invisible Clear Aligners Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: June 7, 2018 Received: June 12, 2018
Dear Bill Jacqmein:
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
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) SUMMARY K173784
| Submitter: | | 48890 Milmont Drive
Fremont, CA 94538 |
|------------------------------|------------------|-------------------------------------------------------------------------------------|
| Company Contact
Person: | | Renjith S Menon, CEO |
| | Phone:
Email: | (510) 868-2184
rmemon@smylio.com |
| Submission
Correspondent: | | Bill Jacqmein, Regulatory Affairs Consultant |
| Address: | Phone:
Email: | 11218 Zest Ct. NE, Blaine, MN 55449
(404) 216-6190
bjacqmein@rcqsolutions.com |
| Date Prepared: | | June 6th, 2018 |
| Proprietary Name: | | Smylio Invisible Clear Aligners |
| Common Name: | | Orthodontic Plastic Brackets |
| Product Code: | | NXC - Orthodontic Plastic Brackets |
| Device Classification: | | Class II, 21 CFR 872.5470 |
| Primary Predicate
Device: | | Derby Dental Laboratory Custom Clear Aligner System
(K173785) |
| Reference Predicates: | | 3Shape OrthoSystem™ Software (K152086)
ClearCorrect System (K113618) |
Device Description:
The Smylio Invisible Clear Aligners are intraoral thermoformed plastic aligners 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.
Smylio Invisible Clear Aligners are fabricated using a three-step process.
The first step 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. This scanned data (digital CAD/CAM models or patient models) are imported into specialized dental software for treatment planning.
3
The second step is the printing of 3D models of the treatment plan for use in step 3 (thermoforming). In the second step, the doctor 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. A 3D printer is used to create the molds 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 a standard thermoforming equipment and the appropriate material as outlined in this submission.
Software Description
Specialized orthodontic CAD/CAM software will be used to develop the treatment plans and to produce standard 3D printer files that will facilitate the manufacturing of each sequential aligner in the treatment plan. The software application used for the manufacturing validation in this submission is the 3Shape®.
Material:
The material used for the manufacturing validation in this submission is the Zendura®.
Indications for Use:
The Smylio Invisible Clear Aligners is indicated for use in the alignment of permanent teeth through orthodontic treatment of misalignment and malocclusion.
Comparison to Predicate Devices:
| Table 1: Functional Specification Comparison | ||
|---|---|---|
| Functional | ||
| Specification | Smylio Invisible Clear | |
| Aligners | Custom Clear Aligner | |
| System (K173785) | ||
| Material | Co-polyester or Co-Polymer | Co-polyester or Co- |
| Polymer | ||
| Mode of Action | Continuous gentle force | |
| applied to teeth to achieve | ||
| movement | Continuous gentle force | |
| applied to teeth to achieve | ||
| movement | ||
| Features: | ||
| Device Description | Sequential thermoformed | |
| plastic aligners | Sequential thermoformed | |
| plastic aligners | ||
| Patient | ||
| Removable? | Yes | Yes |
| Duration of Use | 20 to 22 hours per day | 20 to 22 hours per day |
| Indication for Use | The Smylio Invisible Clear | |
| Aligners is indicated for use in | ||
| the alignment of permanent | ||
| teeth through orthodontic | ||
| treatment of misalignment | ||
| and malocclusion. | The Custom Clear Aligner | |
| is indicated for use in the | ||
| alignment of permanent | ||
| teeth through orthodontic | ||
| treatment of misalignment | ||
| and malocclusion. |
4
Comparison of Indications for Use to Predicate Devices:
Based on the above comparison, the indications for use of the Smylio Invisible Clear Aligners is similar to that of the Derby Dental Custom Clear Aligner (K173785).
Comparison of Technological Characteristics to Predicate Devices:
Based on the above comparison, the design and construction of the Smylio Invisible Clear Aligners is similar to that of the Derby Dental Custom Clear Aligner (K173785).
Non-clinical performance testing:
Manufacturing Validation
A manufacturing validation was performed to demonstrate the dimensional accuracy of the manufacturing process for Smylio Aligners. Three critical aspects of the manufacturing process were assessed for accuracy: digital dentition models from treatment planning, 3D printed molds, and the final thermoformed aligners.
An independent 3rd party software and digital calipers were used to perform point-to-point and critical displacement measurements.
All translational measurements were within 0.3 mm of the target input value and all rotational measurements were within 3° of the target input value, the predefined tolerance of the manufacturing process. There were no statistical differences in the intended and measured values observed from any of the groups. This test has met the pre-established acceptance criteria to demonstrate dimensional accuracy.
Biocompatibility
A biocompatibility assessment was conducted. The Smylio Invisible Clear Aligners have been tested and shown to be compliant with the following standards:
- · ISO 7405:2008 Dentistry Evaluation of biocompatibility of medical devices used in dentistry
Clinical performance testing:
Clinical performance testing was not conducted.
Conclusion:
Based on comparison of indications for use, technological characteristics, performance testing, biocompatibility assessment, we believe that Smylio Invisible Clear Aligners are substantially equivalent to the predicate devices.
5
Indications for Use
510(k) Number (if known) K173784
Device Name Smylio Invisible Clear Aligners
Indications for Use (Describe)
The Smylio Invisible Clear Aligners is indicated for use in the alignment teeth 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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