(204 days)
No
The summary describes a clear aligner system and mentions image processing for 3D data transformation, but there is no mention of AI, ML, or related concepts like neural networks, training sets, or performance metrics typically associated with AI/ML algorithms.
Yes
The device is indicated for the "treatment of tooth malocclusion," which is a medical condition, and it applies "continuous gentle force" to reposition teeth, thereby serving a therapeutic purpose.
No
The device is described as a system for positioning teeth by applying continuous gentle force, not for diagnosing malocclusion or other conditions. Its function is therapeutic/corrective.
No
The device description explicitly states the system is fabricated of "clear thin thermoformed plastics," which are physical components, not software.
Based on the provided information, the UniSmile Clear Aligner System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of tooth malocclusion by physically repositioning teeth. This is a therapeutic device, not a diagnostic one.
- Device Description: The device is a physical appliance (clear aligners) that applies force to teeth. It does not analyze biological samples or provide diagnostic information.
- Image Processing: While image processing is mentioned, it's used to create the physical aligners for treatment, not for diagnosing a condition.
- Anatomical Site: The device interacts with the mouth and teeth, which are part of the body, not a sample taken from the body for analysis.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The UniSmile Clear Aligner System does not fit this description.
N/A
Intended Use / Indications for Use
The UniSmile Clear Aligner System is indicated for the treatment of tooth malocclusion in patients with permanent dentition. The UniSmile Clear Aligner System positions teeth by way of continuous gentle force.
Product codes (comma separated list FDA assigned to the subject device)
NXC
Device Description
The UniSmile Clear Aligner System is fabricated of clear thin thermoformed plastics in a sequential series to progressively reposition the teeth. Corrective force to reposition the teeth is delivered via minor changes into a position in each subsequent aligner.
Mentions image processing
Cases are submitted by the dental professionals and images of patient teeth structures are transformed to three-dimensional data
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Mouth, mucosal membranes
Indicated Patient Age Range
patients with permanent dentition.
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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)
Not Found
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.
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January 30, 2020
Vitang Technology, LLC Xiangxu Chen Vice President of Regulatory and R&D 14662 Franklin Ave, Unit H Tustin, California 92780
Re: K191837
Trade/Device Name: UniSmile Clear Aligner System Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic plastic bracket Regulatory Class: Class II Product Code: NXC Dated: October 25, 2019 Received: November 1, 2019
Dear Xiangxu Chen:
This letter corrects our substantially equivalent letter of January 29, 2020.
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,
For Srivinas 'Nandu' Nandkumar, Ph.D. Director DHT1B: Division of Dental 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) K191837
Device Name UniSmile Clear Aligner System
Indications for Use (Describe)
The UniSmile Clear Aligner System is indicated for the treatment of tooth malocclusion in patients with permanent dentition. The UniSmile Clear Aligner System positions teeth by way of continuous gentle force.
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/3/Picture/0 description: The image contains the logo for Vitang Technology. The logo consists of a blue geometric shape resembling the letter 'T' on the left. To the right of the shape is the company name, 'Vitang Technology', with 'Technology' in a slightly lighter shade of blue. The text 'K191837' is at the top of the image.
Vitang Technology, LLC Traditional 510(k) Premarket Submission Vitang UniSmile Clear Aligner System
K191837
510(k)Summary
UniSmile Clear Aligner System
| Submitter Name: | Vitang Technology LLC |
|---|---|
| Submitter Address: | 14662 Franklin Ave, Unit H, Tustin, CA 92780 |
| Phone Number: | 773-236-7691 |
| Contact Person: | Xiangxu Chen |
| Date Prepared: | 1/29/2020 |
| Device Trade Name: | UniSmile Clear Aligner System |
| Common Name: | Aligner, sequential |
| Classification Name: | Orthodontic Plastic Bracket |
| Classification | |
| Number: | 21 CFR 872.5470 |
| Product Code: | NXC |
| Regulatory Class | 2 |
| Primary Predicate | K113618, ClearCorrect System |
| Reference Device | K181112, Orchestrate 3D |
| Device Description | The UniSmile Clear Aligner System is fabricated of clear thin |
| thermoformed plastics in a sequential series to progressively | |
| reposition the teeth. Corrective force to reposition the teeth is | |
| delivered via minor changes into a position in each subsequent | |
| aligner. | |
| Indications for Use | The UniSmile Clear Aligner System is indicated for the treatment of |
| tooth malocclusion in patients with permanent dentition. The | |
| UniSmile Clear Aligner System positions teeth by way of continuous | |
| gentle force. | |
| Summary of Usage | UniSmile Clear Aligner System consists of a series of clear |
| plastic aligners that offer a solution for aesthetic orthodontic | |
| treatment by utilizing a set of removable aligners to incrementally | |
| move the patient's teeth from an original state to a treated state that | |
| corrects tooth malocclusions. | |
| Cases are submitted by the dental professionals and images of | |
| patient teeth structures are transformed to three-dimensional data |
|
| Design and
Manufacturing Flow
chart | This is a device that requires prescription by order of a dental practitioner. Based on the patient information from a dental practitioner, the treatment plan is designed with a software. The treatment plan is then forwarded to the dental practitioner for review. Once approved, the aligners are manufactured by thermal forming on digitally printed models. Clear aligners are delivered to the practitioner. Each aligner is used by the patient, with instructions. |
| | Page 2 of 4 |
| | • Each aligner is designed for single use within a defined period
of time, such as 2 weeks/aligner.
• It is not sterilized.
• It does not contain drugs or biological substances.
|
| Software | Software is used to design treatment plans. The software used with
UniSmile Clear Aligner System is the Orchestrate 3D (K181112)
software, version OrthoRx 4. |
| Clear Aligner
Materials Testing | Performance properties have been tested and approved for clear
aligner applications. |
| Biocompatibility | Biocompatibility testing has been provided according to ISO-10993 |
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Image /page/4/Picture/0 description: The image contains the logo for Vitang Technology, along with the identifier K191837. The logo features a stylized letter 'T' in shades of blue, presented in a three-dimensional form. To the right of the 'T' is the company name, 'Vitang Technology,' with 'Vitang' in a darker blue and 'Technology' in a lighter blue hue.
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Image /page/5/Picture/0 description: The image contains the logo for Vitang Technology. The logo consists of a stylized blue "T" shape on the left and the words "Vitang Technology" in blue on the right. The word "Technology" is slightly smaller and a lighter shade of blue than the word "Vitang". There is also a serial number "K191837" at the top of the image.
Comparison with Predicate Device
| | UniSmile Clear
Aligners | ClearCorrect System | Comparison |
|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | K191837 | K113618 | |
| Regulation number | 21 CFR 872.5470 | 21 CFR 872.5470 | same |
| Device
common/classification
name | Aligner, sequential | Sequential Aligner | same |
| Product Code | NXC | NXC | |
| Indications for use | The UniSmile Clear Aligner
System is indicated for the
treatment of tooth
malocclusion in patients with
permanent dentition. The
UniSmile Clear Aligner
System positions teeth by
way of continuous gentle
force. | The ClearCorrect System is
indicated for the treatment
of tooth malocclusion in
patients with permanent
dentition (i.e. all second
molars). The ClearCorrect
System positions teeth by
way of continuous gentle
force. | Same |
| Device Description | The UniSmile Clear Aligner
System is fabricated of clear
thin thermoformed plastics in
a sequential series to
progressively reposition the
teeth. Corrective force to
reposition the teeth is
delivered via minor changes
into a position in each
subsequent aligner. | The ClearCorrect device
is fabricated of clear thin
thermoformed
polyurethane plastic in a
sequential series to
progressively reposition
the teeth. Corrective
force to straighten the
teeth is delivered via
minor changes into a
position in each subsequent
aligner. | Same |
| Mode of Action | A set of removable aligners
incrementally move the | Orthodontic tooth
movement occurs | Same |
| | patient's teeth from an
original state to a treated
state through forces applied
by the appliance that corrects
tooth malocclusions. The
programmed displacement is
based on a doctor's
prescription. | through forces applied by
the appliance to the
dentition as each tooth
follows the programmed
displacement based on a
doctor's prescription. | |
| Anatomy Location | Mouth, mucosal membranes | Mouth, mucosal membranes | Same |
| Size/Dimension | Patient and treatment
progress specific | Patient and treatment
progress specific | Same |
| Method of
Manufacturing | Thermoforming | Thermoforming | Same |
| Material | Thermoplastic copolyester | Thermoplastic polyurethane | Similar. Both are
thermoplastic
forming
materials that do
not raise any
additional
questions of safety
or efficacy |
| Material Hardness | $80 \pm 2$ Shore D durometer | $80 \pm 2$ Shore D durometer | Same |
| Material Tensile
Modulus | Tensile modulus is
acceptable for as an
orthodontic base material | Information not available | Good for
orthodontic clear
aligner
applications |
| Material Tensile
Strength | Tensile strength is acceptable
for as an orthodontic base
material | Information not available | Good for
orthodontic clear
aligner
applications |
| Biocompatibility | Passed ISO 10993-1
assessment
• Cytotoxicity
• Intracutaneus Intradermal
reactivity
• Sensitivity | Passed ISO 10993-1
asseessment
• Cytotoxicity
• Intracutaneus Intradermal
reactivity | Same |
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Image /page/6/Picture/0 description: The image contains the text "K191837" at the top. Below that is a logo for "Vitang Technology". The logo consists of a blue geometric shape resembling a stylized letter "T" on the left, followed by the company name in blue font, with the "ec" in "Technology" being a lighter shade of blue.
Conclusion of Substantial Equivalence
UniSmile Clear Aligner System have substantially equivalent Indications for Use as the identified predicate and reference devices. UniSmile Clear Aligner System are substantially equivalent to the predicate device in the technological characteristics, design and device features.