(30 days)
No
The description focuses on the digital design and manufacturing process based on professional approval, with no mention of AI/ML in the design or treatment planning.
Yes
The device is indicated for the "alignment of teeth during orthodontic treatment of malocclusion," which is a therapeutic purpose. It facilitates tooth movement to correct malocclusion, thus treating a medical condition.
No
The device description indicates that Smylio Invisible Clear Aligners are used for the "alignment of teeth during orthodontic treatment" and "facilitate the movement to the final desired position," which describes a therapeutic function rather than a diagnostic one. The device uses pre-existing digital scans of a patient's dentition and relies on a dental health professional to design and approve the sequential dental models for treatment, rather than providing a diagnosis itself.
No
The device description clearly states that the device is comprised of "thermoformed plastic aligners," which are physical hardware components, not solely software.
Based on the provided information, the Smylio Invisible Clear Aligners are not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are used outside of the body to analyze biological specimens.
- Smylio Aligners' Function: The Smylio Invisible Clear Aligners are physical devices worn inside the mouth to mechanically move teeth. They are a form of orthodontic appliance.
- Intended Use: The intended use is for "alignment of teeth during orthodontic treatment of malocclusion," which is a mechanical process, not a diagnostic test on a biological sample.
- Device Description: The description details the physical nature of the aligners, how they are manufactured, and how they are used to apply force to teeth. There is no mention of analyzing biological samples.
Therefore, the Smylio Invisible Clear Aligners fall under the category of a medical device used for treatment, not an in vitro diagnostic device used for diagnosis.
N/A
Intended Use / Indications for Use
The Smylio Invisible Clear Aligners are indicated for the alignment of teeth during orthodontic treatment of malocclusion.
Product codes
NXC
Device Description
The Smylio Invisible Clear Aligners are thermoformed plastic aligners designed to be worn in sequence to facilitate the movement to the final desired position. The sequential aligners introduce incremental movements that move teeth by way of gentle continuous force. The aligners are to be worn 20 to 22 hours a day and are to be removed for eating and for cleaning.
Smylio Invisible Clear Aligners are designed from digital scans of a patient's dentition submitted by a dental health professional (e.g. dentist or orthodontist). Using the scan, sequential dental models are designed and approved by the treating physician prior to manufacturing.
Once the treatment plan is reviewed and approved by a dental health professional, each 3D model from the treatment plan is manufactured. The aligner trays are then manufactured by thermoforming a dental thermoplastic sheet over each model. The aligner trays are then delivered to the patients' dental health professional then monitors their treatment of the first aligner to the delivery of the final aligner.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
digital scans
Anatomical Site
teeth / dentition
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental health professional (e.g. dentist or orthodontist)
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
Non-clinical performance testing:
The use of thermoplastic materials for sequential aligners intended to treat malocclusions has been well documented in scientific literature regarding incremental tooth moving forces. However, durability testing was conducted on the aligners. Real world use was simulated to ensure that the aligner material and manufacturing process produced aligners that were suitable for their prescribed period of use.
An internal manufacturing validation was performed to test the manufacturing process for Smylio Invisible Clear Aligners. The robustness of the process was demonstrated from 3D printing through thermoforming.
The thermoplastic material used for Smylio Invisible Clear Aligners has passed the required testing for material characterization. Material testing was conducted on the aligner material according to ASTM D790-10: Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials. Biocompatibility testing for the aligner material, the only patient contacting material, was conducted in accordance with International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". Additional cytotoxicity testing according to ISO 10993-5:2009 was performed on final manufactured Smylio Invisible Clear Aligners.
Clinical performance testing:
Clinical performance testing was not conducted for this 510(k) Notification. Clinical performance testing was not needed to establish substantial equivalence to the predicate device or to characterize performance. The above-mentioned non-clinical test data characterizes all performance aspects of the device based on well-established scientific and engineering principles.
Key Metrics
Not Found
Predicate Device(s)
Spark Clear Aligner System (K203737)
Reference Device(s)
Invisalign System (K143630), Smylio Invisible Clear Aligners (K173784)
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 shows the logo for 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 text logo on the right. The text logo is in blue and reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in a sans-serif font. The FDA logo is a recognizable symbol of the agency's role in protecting public health.
September 22, 2021
Smylio, Inc % Breanne Butler Regulatory Affairs Consultant Prime Path Medtech 1321 Upland Dr. Suite 6792 Houston, Texas 77043
Re: K212660
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: August 19, 2021 Received: August 23, 2021
Dear Breanne Butler:
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 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
2
Indications for Use
510(k) Number (if known) K212660
Device Name Smylio Invisible Clear Aligners
Indications for Use (Describe)
The Smylio Invisible Clear Aligners are indicated for the alignment of teeth during orthodontic treatment of 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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3
Section 5. 510(k) Summary
510(k) SUMMARY
A summary of 510(k) safety and effectiveness information for this special 510(k) in accordance with the requirements of 21 CFR 807.92.
| Submitter: | Smylio, Inc.
48890 Milmont Dr.
Fremont, CA 94538 |
|-----------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| Company Contact Person:
Phone:
Email: | Renjith S Menon, CEO
(510) 868-2184
rmenon@orthofx.com |
| Submission Correspondent:
Address:
Phone:
Email: | Breanne Butler, Regulatory Affairs Consultant
1321 Upland Dr. Suite 6792 Houston, TX 7704
860-810-5594
bbutler@primepathmedtech.com |
| Date Prepared: | August 2nd, 2021 |
| Proprietary Name: | Smylio Invisible Clear Aligners |
| Common Name: | Orthodontic plastic bracket. |
| Product Code: | NXC – Orthodontic plastic bracket. |
| Device Classification: | Class II, 21 CFR 872.5470 |
| Primary Predicate Device: | Spark Clear Aligner System (K203737) |
| Reference Predicates: | Invisalign System (K143630)
Smylio Invisible Clear Aligners (K173784) |
Device Description:
The Smylio Invisible Clear Aligners are thermoformed plastic aligners designed to be worn in sequence to facilitate the movement to the final desired position. The sequential aligners introduce incremental movements that move teeth by way of gentle continuous force. The aligners are to be worn 20 to 22 hours a day and are to be removed for eating and for cleaning.
Smylio Invisible Clear Aligners are designed from digital scans of a patient's dentition submitted by a dental health professional (e.g. dentist or orthodontist). Using the scan, sequential dental models are designed and approved by the treating physician prior to manufacturing.
Once the treatment plan is reviewed and approved by a dental health professional, each 3D model from the treatment plan is manufactured. The aligner trays are then manufactured by thermoforming a dental thermoplastic sheet over each model. The aligner trays are then delivered to the patients'
4
dental health professional then monitors their treatment of the first aligner to the delivery of the final aligner.
Indications for Use:
The Smylio Invisible Clear Aligners are indicated for the alignment of teeth during orthodontic treatment of malocclusion.
Comparison to Predicate Devices:
Smylio Invisible Clear Aligners are functionally equivalent to the following predicate device: Spark Clear Aligner System (K203737, cleared March 22, 2021) and to the previously cleared reference device, Smylio Invisible Clear Aligners (K173784). The following table demonstrates the functional specifications of Smylio Invisible Clear Aligners are substantially equivalent to the predicate devices.
| Device Comparison Table | ||||||
|---|---|---|---|---|---|---|
| Specification | Subject Device: | |||||
| Smylio Invisible Clear | ||||||
| Aligners | Predicate Device: | |||||
| Spark Clear Aligner | ||||||
| System (K203737) | Reference Device: | |||||
| Smylio Invisible Clear | ||||||
| Aligners (K173784) | Comparison | |||||
| Result | ||||||
| Regulation | ||||||
| Number | 21 CFR 872.5470 | 21 CFR 872.5470 | 21 CFR 872.5470 | Same | ||
| Classification | ||||||
| Name | Orthodontic Plastic | |||||
| Bracket | Orthodontic Plastic | |||||
| Bracket | Orthodontic Plastic | |||||
| Bracket | Same | |||||
| Product Code | NXC | NXC | NXC | Same | ||
| Classification | Class II | Class II | Class II | Same | ||
| OTC or Rx | Rx | Rx | Rx | Same | ||
| Material | Thermoplastic | |||||
| polyurethane- | ||||||
| polyester composite | ||||||
| resin | Thermoplastic | |||||
| polyurethane- | ||||||
| polyester composite | ||||||
| resin | Co-polyester or co- | |||||
| polymer | Same as | |||||
| predicate | ||||||
| Material | ||||||
| Properties | Acceptable material | |||||
| properties established | ||||||
| for use as an aligner. | Acceptable materials | |||||
| properties established | ||||||
| for use as an aligner. | Acceptable materials | |||||
| properties established | ||||||
| for use as an aligner. | Same | |||||
| Material | ||||||
| Testing | ASTM D790-10: | |||||
| Standard Test | ||||||
| Methods for Flexural | ||||||
| Properties of | ||||||
| Unreinforced and | ||||||
| Reinforced Plastics and | ||||||
| Electrical Insulating | ||||||
| Materials. | ASTM D790-10: | |||||
| Standard Test | ||||||
| Methods for Flexural | ||||||
| Properties of | ||||||
| Unreinforced and | ||||||
| Reinforced Plastics and | ||||||
| Electrical Insulating | ||||||
| Materials. | ASTM D790-10: | |||||
| Standard Test | ||||||
| Methods for Flexural | ||||||
| Properties of | ||||||
| Unreinforced and | ||||||
| Reinforced Plastics and | ||||||
| Electrical Insulating | ||||||
| Materials. | Same | |||||
| Biocompatible | Biocompatible | |||||
| according to ISO | ||||||
| 10993-1 (Biological | ||||||
| evaluation of medical | ||||||
| devices — Part 1: | ||||||
| Evaluation and testing | ||||||
| within a risk | ||||||
| management system). | Biocompatible | |||||
| according to ISO | ||||||
| 10993-1 (Biological | ||||||
| evaluation of medical | ||||||
| devices - Part 1: | ||||||
| Evaluation and testing | ||||||
| within a risk | ||||||
| management system). | Biocompatible | |||||
| according to ISO | ||||||
| 10993-1 (Biological | ||||||
| evaluation of medical | ||||||
| devices - Part 1: | ||||||
| Evaluation and testing | ||||||
| within a risk | ||||||
| management system). | Same | |||||
| Sterile | Non-sterile | Non-sterile | Non-sterile | Same |
5
| Specification | Subject Device:
Smylio Invisible Clear
Aligners | Predicate Device:
Spark Clear Aligner
System (K203737) | Reference Device:
Smylio Invisible Clear
Aligners (K173784) | Comparison
Result |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|
| Device
Description | Sequential
thermoformed plastic
aligners | Sequential
thermoformed plastic
aligners | Sequential
thermoformed plastic
aligners | Same |
| Patient
Removable? | Yes | Yes | Yes | Same |
| Indication for
Use | The Smylio Invisible
Clear Aligners are
indicated for the
alignment of teeth
during orthodontic
treatment of
malocclusion. | The Spark™ Clear
Aligner System is
indicated for the
alignment of teeth
during orthodontic
treatment of
malocclusion. | The Smylio Invisible
Clear Aligners is
indicated for use in the
alignment of
permanent teeth
through orthodontic
treatment of
misalignment
and malocclusion. | Same as
predicate. |
| Intended Use | Orthodontic tooth
movement | Orthodontic tooth
movement | Orthodontic tooth
movement | Same |
| Mode of
Action | Continuous gentle
force applied to teeth
following the
prescribed and
approved treatment
plan to achieve
orthodontic movement | Continuous gentle
force applied to teeth
following the
prescribed and
approved treatment
plan to achieve
orthodontic movement | Continuous gentle
force applied to teeth
following the
prescribed and
approved treatment
plan to achieve
orthodontic movement | Same |
Comparison of Indications for Use to Predicate Devices and Previously Cleared Devices:
The indications for use of the Smylio Invisible Clear Aligners in this submission is the Spark Clear Aligner System (K203737) as they are both indicated for use in the alignment of teeth through orthodontic treatment of malocclusion. The differences between the indications for use of the subject device and the previously cleared device (K173784) do not raise questions of substantial equivalence. The aligners guide teeth to their final position by way of continuous gentle forces. Thus, the Smylio Invisible Clear Aligners can be considered substantially equivalent to its predicate device.
The difference between the Smylio Invisible Clear Aligners in this submission (Subject Device) and the Reference Device, Smylio Clear Aligners (K173784) is the material of the subject device is the same as the predicate device.
Comparison of Technological Characteristics to Predicate Devices:
Based on the above comparison, the design, construction, and performance characteristics of the Smylio Invisible Clear Aligners is the same as the predicate and similar to the reference device. Thus, the Smylio Invisible Clear Aligners can be considered substantially equivalent to its predicate device.
Non-clinical performance testing:
The use of thermoplastic materials for sequential aligners intended to treat malocclusions has been well documented in scientific literature regarding incremental tooth moving forces. However, durability
6
testing was conducted on the aligners. Real world use was simulated to ensure that the aligner material and manufacturing process produced aligners that were suitable for their prescribed period of use.
An internal manufacturing validation was performed to test the manufacturing process for Smylio Invisible Clear Aligners. The robustness of the process was demonstrated from 3D printing through thermoforming.
The thermoplastic material used for Smylio Invisible Clear Aligners has passed the required testing for material characterization. Material testing was conducted on the aligner material according to ASTM D790-10: Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials. Biocompatibility testing for the aligner material, the only patient contacting material, was conducted in accordance with International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". Additional cytotoxicity testing according to ISO 10993-5:2009 was performed on final manufactured Smylio Invisible Clear Aligners.
Clinical performance testing:
Clinical performance testing was not conducted for this 510(k) Notification. Clinical performance testing was not needed to establish substantial equivalence to the predicate device or to characterize performance. The above-mentioned non-clinical test data characterizes all performance aspects of the device based on well-established scientific and engineering principles. .
Conclusion:
Based on similarities in indications for use, technological characteristics, non-clinical performance testing, Smylio Invisible Clear Aligners are substantially equivalent to the Spark Aligner System and the previously cleared Smylio Invisible Clear Aligners (K173784).