(313 days)
No
The description focuses on the physical aligners and the digital design process, which is explicitly stated to be created and approved by a dental health professional. There is no mention of AI or ML being used in the design or manufacturing process.
Yes
The device is indicated for the "alignment of permanent teeth during orthodontic treatment of malocclusion," which is a therapeutic purpose. The description also details how the device "facilitate[s] the movement to the final desired position" of teeth by "gentle continuous force," resulting in "tooth alignment."
No
Explanation: The device is described as an aligner for orthodontic treatment, specifically for the alignment of permanent teeth. It is used to facilitate tooth movement and applies continuous force to move teeth. There is no mention of the device being used to diagnose any medical condition or disease.
No
The device is a physical, thermoformed plastic aligner, not a software-only device. While it utilizes digital scans and a digital treatment plan, the core medical device is the physical aligner itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Smylio Nightwear Aligners are physical devices designed to be worn in the mouth to physically move teeth for orthodontic treatment. They do not analyze biological samples to provide diagnostic information.
- Intended Use: The intended use is for "alignment of permanent teeth during orthodontic treatment of malocclusion," which is a therapeutic purpose, not a diagnostic one.
- Device Description: The description focuses on the physical properties 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 Nightwear Aligners fall under the category of a medical device used for treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Nightwear Aligners are indicated for the alignment of permanent teeth during orthodontic treatment of malocclusion.
Product codes (comma separated list FDA assigned to the subject device)
NXC
Device Description
The Smylio Nightwear 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 at least 9 to 12 hours a day and are to be removed for eating and for cleaning.
Smylio Nightwear 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 aligners are shipped to the treating clinician's office where they are then distributed to the patient in sequential stages. 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 of a patient's dentition
Anatomical Site
Mouth; mucosal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental health professional (e.g., dentist or orthodontist), treating clinician's office
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)
Non-clinical performance testing: Durability testing was conducted on the Smylio Nightwear 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. Material property testing was performed to investigate elongation, tensile and flexural properties of the material in accordance with ASTM D638 and ASTM D790. An internal manufacturing validation was performed to test the manufacturing process for Smylio Nightwear Aligners. The robustness of the process was demonstrated from 3D printing through thermoforming. Biocompatibility testing for the aligner material, the only patient contacting material, was in accordance with the International Standard "Biological evaluation of medical devices" ISO 10993-1, ISO 10993-5:2009, ISO 10993-10:2010, ISO 10993-10:2010, and ISO 10993-11:2017.
Clinical performance testing: Clinical performance testing was conducted on 20 patients for the Smylio Nightwear Aligners under an FDA cleared IDE application (G200298). The study results demonstrated that tooth alignment may occur for patients with at least 9 to 12 hours of wear time per day for one week prior to moving to the next aligner for patients with mild malocclusions as determined by the treating dentist.
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.
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.
0
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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 5, 2023
Smylio Inc. % Jennifer Day Regulatory Affairs Consultant Prime Path Medtech 1321 Upland Dr. Suite 6792 Houston, Texas 77043
Re: K221537
Trade/Device Name: Nightwear Aligners Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: May 26, 2022 Received: May 27, 2022
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 (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.
1
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 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 -S
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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K221537
Device Name Nightwear Aligners
Indications for Use (Describe)
Nightwear Aligners are indicated for the alignment of permanent 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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Attachment A: 510(k) Summary
510(k) SUMMARY
A summary of 510(k) safety and effectiveness information for this submission in accordance with the requirements of 21 CFR 807.92.
| Submitter: | Smylio Inc.
48890 Milmont Dr
Suite 101D
Fremont CA, 94538 |
|---------------------------|----------------------------------------------------------------------------------------|
| Company Contact Person: | Ren Menon, CEO |
| Phone: | 510-868-2184 |
| Email: | rmenon@orthofx.com |
| Submission Correspondent: | Jennifer Day, Regulatory Affairs Consultant
Breanne Butler, PhD |
| Company: | Prime Path Medtech Inc. |
| Address: | 1321 Upland Dr, Ste 6792 Houston, TX 77043 |
| Phone: | 860-810-5594 |
| Email: | jday@primepathmedtech.com |
| Date Prepared: | May 26, 2022 |
| Proprietary Name: | Smylio Nightwear Aligners |
| Common Name: | Orthodontic plastic bracket. |
| Product Code: | NXC – Orthodontic plastic bracket. |
| Device Classification: | Class II, 21 CFR 872.5470 |
| Primary Predicate Device: | iSMILE Aligners (K200908) |
| Reference Predicates: | Smylio Invisible Clear Aligners (K212660)
Smylio Invisible Clear Aligners (K172784) |
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Device Description:
The Smylio Nightwear 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 at least 9 to 12 hours a day and are to be removed for eating and for cleaning.
Smylio Nightwear 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 aligners are shipped to the treating clinician's office where they are then distributed to the patient in sequential stages. The patients' dental health professional then monitors their treatment of the first aligner to the delivery of the final aligner.
Indications for Use:
Nightwear Aligners are indicated for the alignment of permanent teeth during orthodontic treatment of malocclusion.
Comparison to Predicate Devices:
Smylio Nightwear Aligners are functionally equivalent to the following predicate device: iSMILE Aligners (K200908). The following table demonstrates the functional specifications of Smylio Nightwear Aligners are substantially equivalent to the predicate devices.
| Specification | Subject Device: Smylio
Nightwear Aligners | Predicate Device: iSMILE
Aligners (K200908) | Comparison
Result |
|------------------------|----------------------------------------------|------------------------------------------------|----------------------|
| Regulation
Number | 21 CFR 872.5470 | 21 CFR 872.5470 | Same |
| Classification
Name | Orthodontic Plastic Bracket | Orthodontic Plastic Bracket | Same |
| Product Code | NXC | NXC | Same |
| Classification | Class II | Class II | Same |
Table 1. Predicate Device Comparison Table
5
| Specification | Subject Device: Smylio
Nightwear Aligners | Predicate Device: iSMILE
Aligners (K200908) | Comparison
Result |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| OTC or Rx | Rx | Rx | Same |
| Material | Thermoplastic Polymer | Thermoplastic Polymer | Same |
| Material
Properties | Demonstrates sufficient
tensile strength, elasticity,
ductility, chemical resistance,
and clarity for use as a clear
tray aligner. | Demonstrates sufficient
tensile strength, elasticity,
ductility, chemical resistance,
and clarity for use as a clear
tray aligner. | Same |
| Biocompatible | Yes | Yes | Same |
| Specification | Subject Device: Smylio
Nightwear Aligners | Predicate Device: iSMILE
Aligners (K200908) | Comparison
Result |
| Device
Description | Nightwear Aligners are a
sequence of transparent
aligners created from a
digital orthodontic treatment
plan. The Nightwear Aligners
are fabricated of a
transparent thermoformed
polyurethane plastic. Each
aligner delivers a unique
combination of minor forces
to create the planned tooth
movement. The digital
orthodontic treatment plan
is created by a dental health
professional.
The Nightwear Aligners
incorporate the use of
attachments to create spaces
and force points in order to
cause minor tooth
movement. These force
points are located in specific
areas and positioned in such
a way that they provide a
continuous force which
slowly dissipates over time
on the tooth to be moved for
as long as the aligner is worn. | The iSMILE is a sequence of
transparent aligners created
from a digital orthodontic
treatment plan. The iSMILE
aligner is fabricated of a
transparent thermoformed
polyurethane plastic. Each
aligner delivers a unique
combination of minor forces
to create the planned tooth
movement. The digital
orthodontic treatment plan
is created by a dental health
professional.
The iSMILE Aligner
incorporates the use of
attachments to create spaces
and force points in order to
cause minor tooth
movement. These force
points are located in specific
areas and positioned in such
a way that they provide a
continuous force which
slowly dissipates over time
on the tooth to be moved for
as long as the aligner is worn. | Same |
| Anatomy
Location | Mouth; mucosal | Mouth; mucosal | Same |
| Size | Patient Specific | Patient Specific | Same |
| Specification | Subject Device: Smylio
Nightwear Aligners | Predicate Device: iSMILE
Aligners (K200908) | Comparison
Result |
| Manufacturing
Method | Thermoforming | Thermoforming | Same |
| Patient
Removable? | Yes | Yes | Same |
| Indication for
Use | Nightwear Aligners are
indicated for the alignment
of permanent teeth during
orthodontic treatment of
malocclusion. | iSMILE is indicated for the
alignment of teeth during
orthodontic treatment of
malocclusion. | Same |
| Mode of
Action | Orthodontic tooth
movement occurs through
forces applied by the
appliance 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
appliance to the dentition as
each tooth follows the
programmed displacement
based on a doctor's
prescription | Same |
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7
Comparison of Indications for Use to Predicate Devices:
The indications for use of the Smylio Nightwear Aligners are the iSMILE Aligners (K200908) as they are both indicated for use in the alignment of permanent teeth through orthodontic treatment of misalignment and malocclusion. The aligners guide teeth to their final position by way of continuous gentle forces. Thus, the Smylio Nightwear Aligners can be considered substantially equivalent to its predicate device.
Comparison of Technological Characteristics to Predicate Devices:
Based on the above comparison, the design, construction, and performance characteristics of the Smylio Nightwear Aligners is similar to that of the iSMILE Aligners (K200908). Thus, the Smylio Nightwear 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.
8
However, durability testing was conducted on the Smylio Nightwear 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.
Material property testing was performed to investigate elongation, tensile and flexural properties of the material in accordance with ASTM D638 and ASTM D790.
An internal manufacturing validation was performed to test the manufacturing process for Smylio Nightwear Aligners. The robustness of the process was demonstrated from 3D printing through thermoforming.
The thermoplastic material used for Smylio Nightwear Aligners is broadly used in many aligners. Biocompatibility testing for the aligner material, the only patient contacting material, was in accordance with the International Standard "Biological evaluation of medical devices" ISO 10993-1, ISO 10993-5:2009, ISO 10993-10:2010, ISO 10993-10:2010, and ISO 10993-11:2017.
Clinical performance testing:
Clinical performance testing was conducted on 20 patients for the Smylio Nightwear Aligners under an FDA cleared IDE application (G200298). The study results demonstrated that tooth alignment may occur for patients with at least 9 to 12 hours of wear time per day for one week prior to moving to the next aligner for patients with mild malocclusions as determined by the treating dentist.
Conclusion:
Based on similarities in indications for use, technological characteristics, non-clinical performance testing, and clinical performance testing, Smylio Nightwear Aligners are substantially equivalent to the iSMILE Aligners (K200908).