(141 days)
Not Found
No
The 510(k) summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on traditional dental software and manufacturing processes. While the device name includes "AI", the summary provides no evidence of AI/ML technology being used in the device's function or design process as described.
Yes
The device is indicated for the alignment of teeth during orthodontic treatment of malocclusion, which is a therapeutic purpose. It applies gentle pressure to gradually move teeth into alignment.
No
The "Al Smile Aligner" is a treatment device, not a diagnostic one. It is used to apply gentle pressure to teeth to move them into alignment, a therapeutic action, not to identify or detect a disease or condition. The diagnostic steps (assessment, impressions, prescription) are performed by a dental clinician using other tools, not by the aligner itself.
No
The device description clearly states that the device consists of "thin, clear plastic removable orthodontic appliances (aligners)" which are physical hardware components. While software is used in the design process, the final device is a physical product.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "alignment of teeth during orthodontic treatment of malocclusion." This describes a physical intervention on the patient's teeth, not a test performed on a sample taken from the body to provide information about a disease or condition.
- Device Description: The device is a physical appliance (aligners) that applies force to teeth. It's a therapeutic device, not a diagnostic one.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze a sample (blood, urine, tissue, etc.) or to provide diagnostic information. The process involves taking impressions and using software to design a physical treatment plan.
- Performance Studies: The performance studies focus on the physical, chemical, and mechanical properties of the aligners, as well as biocompatibility. These are relevant for a therapeutic device, not an IVD.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
"Al Smile Aligner" is indicated for the alignment of teeth during orthodontic treatment of malocclusion.
Product codes
NXC
Device Description
"Al Smile Aligner" consists of a custom-made series of thin, clear plastic removable orthodontic appliances (aligners) that apply gentle pressure to teeth, gradually moving them into alignment.
A dentist or orthodontist assesses the patient to determine if the patient is a good candidate. Impressions are taken by the dental clinician and submitted to Nanjing Jiahe Dental Technology Co., Ltd along with the physician's prescription.
An FDA cleared dental software used for teeth alignment was used to design a series of plastic aligners intended to gradually realign the patient's teeth in accordance to the doctor's prescription.
Once the treatment plan is reviewed and approved by a dental health professional, each 3D model from the treatment plan is manufactured. The aligner travs are then manufactured by thermoforming a dental thermoplastic sheet over each model.
The "Al Smile Aligners" have the same technological characteristics as the predicate device, in that all the devices are made from commercially available plastic that is thermoformed to create a customized, patient-specific aligners are then used for minor tooth movement by way of continuous gentle force.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Dental mucosal
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
As part of demonstrating substantial equivalence of "Al Smaile Aligner" to the predicate device that are subject to this 510(k) submission, we have completed a number of nonclinical performance tests. "Al Smile Aligner" meets all the requirements for overall design, biocompatibility, and performance results confirming that the design output meets the design inputs and specifications for the device.
Laboratory Testing
- Performance including physical, chemical, and mechanical properties
- Validate the processes used for the design and manufacture of the customized aligners.
- Additionally, mechanical property and elasticity of the thermoformed device were studied following ASTM standards such as ASTM D570, ASTM D638, ASTM D790, and ASTM D1525.
Biocompatibility Testing
The device has been tested according to Good Laboratory Practices for its biocompatibility according to ISO 10993, as follows:
- Part 3 (Ames Assay)
- Part 5 (Cytotoxicity)
- Part 10 (Oral Mucosa Irritation)
- Part 10 (Maximization for Delayed-Type Hypersensitivity)
- Part 11 (Systemic Toxicity)
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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 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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 20, 2022
Nanjing Jiahe Dental Technology Co., Ltd. % Charles Shen Director Manton Business and Technology Services 37 Winding Ridge Oakland. New Jersey 07436
Re: K222308
Trade/Device Name: Al Smile Aligner Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: November 22, 2022 Received: November 22, 2022
Dear Charles Shen:
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 medical devices and radiation-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).
Sincerelv.
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
2
Indications for Use
510(k) Number (if known) K222308
Device Name Al Smile Aligner
Indications for Use (Describe)
"Al Smile Aligner" is indicated for the alignment of teeth during orthodontic treatment of malocclusion.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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K22308
Section 5: 510(k) Summary:
This summary of 510k safety and effectiveness information is being submitted In accordance with the requirements of 21CFR 807.92
Submitter & Foreign Manufacture Identification 5.1
Nanjing Jiahe Dental Technology Co., Ltd. Room 201, Building 2, No.2 Shuanglong Street, Oinhuai District, Naujing, Jiangsu Province, China, Zipcode 210000 Tel: (086) 400-0880468 Submitter's FDA Registration Number: N/A
Contact Person 5.2
Charles Shen Manton Business and Technology Services 37 Winding Ridge, Oakland, NJ 07436 Tel: 608-217-9358 Email: cyshen@aol.com
Date of Summary: July 11, 2022 5.3
| 5.4
| Device Name: | |
|---|---|
| Proprietary Name: | Al Smile Aligner |
| Common Name: | Dental Plastic Aligner |
| Classification Name: | Orthodontic Plastic Brackets - Sequential Aligners |
| Device Classification: | II |
| Regulation Number: | 21 CFR 872.5470 |
| Panel: | Dental |
| Product Code: | NXC |
ર્સ્ટ Predicate Device Information:
K200908, "iSMILE", manufactured by "3D Diagnostix Inc." (1)
ર્સ્વ Device Description:
"Al Smile Aligner" consists of a custom-made series of thin, clear plastic removable orthodontic appliances (aligners) that apply gentle pressure to teeth, gradually moving them into alignment.
A dentist or orthodontist assesses the patient to determine if the patient is a good candidate. Impressions are taken by the dental clinician and submitted to Nanjing Jiahe Dental Technology Co., Ltd along with the physician's prescription.
4
An FDA cleared dental software used for teeth alignment was used to design a series of plastic aligners intended to gradually realign the patient's teeth in accordance to the doctor's prescription.
Once the treatment plan is reviewed and approved by a dental health professional, each 3D model from the treatment plan is manufactured. The aligner travs are then manufactured by thermoforming a dental thermoplastic sheet over each model.
The "Al Smile Aligners" have the same technological characteristics as the predicate device, in that all the devices are made from commercially available plastic that is thermoformed to create a customized, patient-specific aligners are then used for minor tooth movement by way of continuous gentle force.
5.7 Indications for Use:
"Al Smile Aligner" is indicated for the alignment of teeth during orthodontic treatment of malocclusion.
ર્સ્ક Summary of Device Testing:
As part of demonstrating substantial equivalence of "Al Smaile Aligner" to the predicate device that are subject to this 510(k) submission, we have completed a number of nonclinical performance tests. "Al Smile Aligner" meets all the requirements for overall design, biocompatibility, and performance results confirming that the design output meets the design inputs and specifications for the device.
Laboratory Testing
- Performance including physical, chemical, and mechanical properties ●
- . Validate the processes used for the design and manufacture of the customized aligners.
- Additionally, mechanical property and elasticity of the thermoformed device were ● studied following ASTM standards such as ASTM D570, ASTM D638, ASTM D790, and ASTM D1525.
Biocompatibility Testing
The device has been tested according to Good Laboratory Practices for its biocompatibility according to ISO 10993, as follows:
- Part 3 (Ames Assay) ●
- Part 5 (Cytotoxicity) ●
- Part 10 (Oral Mucosa Irritation)
- Part 10 (Maximization for Delayed-Type Hypersensitivity) ●
- Part 11 (Systemic Toxicity) ●
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5.9 Technological Comparison with Predicate Device
The following table shows similarities and differences of use, design, and material between our device and the predicate devices.
| Description | Subject Device | Predicate Device (K200908) | SE
Decision |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|
| Brand Name | Al Smile Aligner | iSMILE | SE |
| Regulation
Number | 21 CFR 872.5470 | 21 CFR 872.5470 | SE |
| Product Code | NXC | NXC | SE |
| Classification | Class 2 | Class 2 | SE |
| Indication for
Use | "Al Smile Aligner" is indicated for the
alignment of teeth during orthodontic
treatment of malocclusion. | iSMILE is indicated for the
alignment of teeth during
orthodontic treatment of
malocclusion. | SE |
| Mode of Action | Alignment of teeth by application of
continuous gentle force, by sequential
use of preformed plastic trays,
fabricated based on doctor's
prescription. | Alignment of teeth by application
of continuous gentle force, by
sequential use of preformed
plastic trays, fabricated based on
doctor's prescription. | SE |
| Materials | Thermoplastic | Thermoplastic | SE |
| Processing | Thermoforming | Thermoforming | SE |
| Dimension | Customized patient specific | Customized patient specific | SE |
| Anatomy
Location | Dental mucosal | Dental mucosal | SE |
| Single Use | Yes | Yes | SE |
| Prescription or
OTC | Rx | Rx | SE |
| Sterile | Non-sterile | Non-sterile | SE |
| Software Use | Yes | Yes | SE |
| Product Picture | Image: Product Picture | Image: Product Picture | SE |
| Biocompatibility | | | |
| Performance | Meet ISO 10993-1 | Meet ISO 10993-1 | SE |
| | Bench Testing and Process Validation | Bench Testing and Process Validation | SE |
6
Our device is essentially identical to the predicate device in terms of indications for use, design, material, and processing between our device and the predicate devices.
5.10 Substantial Equivalence Conclusion
It has been shown in this 510(k) submission that "Al Smile Aligner" and its predicate devices have the identical indications for use, similar composition and biocompatibility, similar manufacturing process, and adequate performance.
The difference between the "Al Smile Aligner" and their predicate device do not raise any question regarding its equivalence.
"Al Smile Aligner", as designed and manufactured, is equivalent to its predicate device, and therefore is substantially equivalent as its predicate device.