(27 days)
Not Found
No
The description focuses on CAD/CAM software for treatment planning and model generation, with no mention of AI or ML for tasks like automated treatment planning, image analysis, or outcome prediction. The "Mentions AI, DNN, or ML" field is also explicitly marked as "Not Found".
Yes
The device is described as an aligner system indicated for the alignment of teeth in patients with malocclusion, directly functioning to correct a medical condition.
No
Explanation: The device is an aligner system used for teeth alignment during orthodontic treatment. While it uses digital data and software for treatment planning, its purpose is to incrementally move teeth, not to diagnose a medical condition.
No
The device description clearly states that the system includes "clear plastic removable aligners" which are physically produced by thermoforming plastic sheets over models. This involves physical hardware components (the aligners themselves) and a manufacturing process beyond just software. While software is used in the design and planning, the final medical device delivered to the patient is a physical product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The 3D Smile Predict aligner system is a physical device (clear plastic aligners) used to mechanically move teeth. It is based on digital scans or impressions of the patient's teeth and a software-generated treatment plan.
- Lack of Specimen Analysis: The device does not analyze any biological specimens from the patient. Its function is entirely external and mechanical.
The device falls under the category of a medical device used for orthodontic treatment, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
3D Smile Predict aligners are indicated for the alignment of teeth in patients with permanent dentition (i.e. all second molars) during orthodontic treatment of malocclusion.
Product codes (comma separated list FDA assigned to the subject device)
NXC
Device Description
The 3D Smile Predict aligner system is a series of prescription-only clear plastic removable aligners intended to incrementally move a patient's teeth from an initial state to a different end state using a software-generated sequence of intermediate states. 3D Smile Predict Aligners sequentially reposition teeth by way of continuous gentle force.
A digital or traditional mold impression of the patient's teeth is provided by a dental health professional (e.g. orthodontist or dentist). From the digital data created of the patient's teeth, specialized orthodontic CAD/CAM software is used to develop treatment plans. Using the software, dental technicians design a series of intermediate models corresponding to each stage of treatment, gradually realigning the patient's teeth according to the dental health professional's prescription.
The prescribing doctor reviews and approves the model scheme and treatment plan before the molds/models are produced.
Once approved, the specialized orthodontic software is used to generate standard format 3D files which are used to physically produce each model/mold in the treatment plan for aligner fabrication. 3D Smile USA, Inc produces the aligner trays by thermoforming a plastic sheet over each model in the treatment plan. The aligner trays are sent to the dental health professional who then delivers them to the patient, confirming fit and design of the first stage of treatment. Additional trays are used sequentially by the patient to gradually move the teeth to the desired position. The dental health professional monitors treatment from the moment the first aligner is delivered to when the final aligner is finished and treatment complete. The aligners are held in place by pressure and can be removed by the patient at any time.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
digital or traditional mold impression of the patient's teeth
Anatomical Site
teeth/dentition
Indicated Patient Age Range
patients with permanent dentition (i.e. all second molars)
Intended User / Care Setting
dental health professional (e.g. orthodontist or dentist)
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)
Due to the difficulty in evaluating this type of dental device in a laboratory environment, no direct performance bench testing of the aligners was performed. The use of thermoplastic materials for sequential aligners intended to treat malocclusions have been well documented in scientific literature regarding incremental tooth moving forces.
A manufacturing validation was performed to demonstrate the dimensional accuracy of the manufacturing process for 3D Smile Predict Aligners. Three critical aspects of the manufacturing process were assessed for accuracy: 3D printed molds, thermoformed aligner adaptation to the mold, thermoformed aligner to the software output.
Inspection software was used to perform point-to-point and critical displacement measurements. All measurements were within the acceptance criteria. These test have met the pre-established acceptance criteria to demonstrate dimensional accuracy.
An aligner fit validation was performed to confirm fit of aligners on the patient.
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.
Not Found
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
February 24, 2020
Image /page/0/Picture/1 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 consists of a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in smaller blue letters below.
3D Smile USA, Inc % Prithul Bom Responsible Third Party Official Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114
Re: K200214
Trade/Device Name: 3D Predict Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic plastic bracket Regulatory Class: Class II Product Code: NXC Dated: January 24, 2020 Received: January 28, 2020
Dear Prithul Bom:
We have reviewed vour 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
1
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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510(k) Summary 3D Smile USA, Inc 3D Smile Predict 12/24/2019
5.1 ADMINISTRATIVE INFORMATION
| Manufacturer Name | 3D Smile USA, Inc |
|---|---|
| 3675 Market Street | |
| Suite #200 | |
| Philadelphia, PA 19104 | |
| USA | |
| Telephone: | +1 (920) 332 4344 |
| Fax: | n/a |
| Official Contact | Marina Domracheva, CEO |
|---|---|
| Email: | marina.domracheva@3d-smile.com |
5.2 DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name: | 3D Smile Predict |
|---|---|
| Common Name: | Aligners, sequential |
| Classification Name: | Orthodontic Plastic Bracket |
|---|---|
| Classification Regulations: | 21 CFR 872.5470 |
| Device Class: | Class II |
| Product Code: | NXC |
| Review Panel: | Dental Products Panel |
| Reviewing Branch: | Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1) |
| Dental Devices (DHT1B) |
PREDICATE DEVICE INFORMATION 5.3
The devices within this submission are substantially equivalent in indications, intended use and design principles to the following predicate and reference devices:
| 510(k) | Predicate Device Name | Company Name |
|---|---|---|
| K191990 | OSW Aligner System | OSW Manufacturing, LLC |
5.4 DEVICE DESCRIPTION
The 3D Smile Predict aligner system is a series of prescription-only clear plastic removable aligners intended to incrementally move a patient's teeth from an initial state to a different end state using a software-generated sequence of intermediate states. 3D Smile Predict Aligners sequentially reposition teeth by way of continuous gentle force.
A digital or traditional mold impression of the patient's teeth is provided by a dental health professional (e.g. orthodontist or dentist). From the digital data created of the patient's teeth, specialized orthodontic CAD/CAM software is used to develop treatment plans. Using the software, dental technicians design a series of intermediate models corresponding to each stage of treatment, gradually realigning the patient's teeth according to the dental health professional's prescription.
3
The prescribing doctor reviews and approves the model scheme and treatment plan before the molds/models are produced.
Once approved, the specialized orthodontic software is used to generate standard format 3D files which are used to physically produce each model/mold in the treatment plan for aligner fabrication. 3D Smile USA, Inc produces the aligner trays by thermoforming a plastic sheet over each model in the treatment plan. The aligner trays are sent to the dental health professional who then delivers them to the patient, confirming fit and design of the first stage of treatment. Additional trays are used sequentially by the patient to gradually move the teeth to the desired position. The dental health professional monitors treatment from the moment the first aligner is delivered to when the final aligner is finished and treatment complete. The aligners are held in place by pressure and can be removed by the patient at any time.
The technology is identical to that used by the Predicate device, OSW Aligner System (K191990) and a number of other sequential aligner systems currently being legally marketed.
5.5 INDICATIONS FOR USE
3D Smile Predict aligners are indicated for the alignment of teeth in patients with permanent dentition (i.e. all second molars) during orthodontic treatment of malocclusion.
EQUIVALENCE TO MARKETED DEVICE 5.6
Overall, the Subject device is substantially equivalent to the Predicate device with respect to Indications for Use and technological principles. The Comparison table below compares parameters and characteristics of the Subject device and Predicate/reference devices.
| Parameter | Subject Device | Predicate Device |
|---|---|---|
| Subject Device | 3D Smile Predict | |
| 3D Smile USA, Inc | OSW Aligner System | |
| OSW Manufacturing, LLC | ||
| K180241 | ||
| Regulation # | 21 CFR 872.5470 | 21 CFR 872.5470 |
| Classification Name | Orthodontic Plastic Bracket | Orthodontic Plastic Bracket |
| Product Code | NXC | NXC |
| Classification | Class II | Class II |
| Indications for Use | 3D Smile Predict aligners are indicated for the alignment of teeth in patients with permanent dentition (i.e. all second molars) during orthodontic treatment of malocclusion. | OSW Aligner System is indicated for the alignment of teeth during orthodontic treatment of malocclusion. |
| Mode of action | Orthodontic movement occurs through continuous gentle forces applied to the dentition as each tooth follows the programmed displacement based on a doctor's prescription. | Orthodontic movement occurs through continuous gentle forces applied to the dentition as each tooth follows the programmed displacement based on a doctor's prescription. |
| Method of use | Each appliance is worn by the patient as determined by the dental practitioner, generally 2 weeks prior to being replaced by the next aligner in sequence. | Each appliance is worn by the patient as determined by the dental practitioner, generally 2 weeks prior to being replaced by the next aligner in sequence. |
| 3D Software | ||
| Description | The 3D Smile Predict 3-D Software uses a scan of a PVS impression, physical or a digital scan (which represents an untreated state) to generate the image of a final, provisional treated state and then interprets a series of images that represent intermediate teeth states. The dental practitioner then reviews these images and has the option to reject or request modifications to the set-up prior to approving it for aligner fabrication. Once the dental practitioner approves the treatment plan, the software converts the files to produce the series of custom-made aligners | The OSW Manufacturing 3-D Software uses a scan of a PVS impression or a digital scan (which represents an untreated state) to generate the image of a final, provisional treated state and then interprets a series of images that represent intermediate teeth states. The dental practitioner then reviews these images and has the option to reject or request modifications to the set-up prior to approving it for aligner fabrication. Once the dental practitioner approves the treatment plan, the software converts the files to produce the series of custom-made aligners |
Predicate Device Comparison Table
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| Parameter | Subject Device | Predicate Device |
|---|---|---|
| 3D Smile Predict | OSW Aligner System | |
| 3D Smile USA, Inc | OSW Manufacturing, LLC | |
| K180241 | ||
| Function of the 3D | ||
| software | The 3D Smile 3-D Software performs the following | |
| operations: | ||
| • Produce 3D-model file of the patient's dentition | ||
| from a digital scan. | ||
| • Generates a treatment plan (i.e. 3-D models that | ||
| represent the treatment plan) called a 3D plan based | ||
| on the prescribing doctor's instructions. The treating | ||
| dental practitioner reviews these images using 3D | ||
| Smile software and has the option to reject or | ||
| request modifications to the set-up prior to | ||
| approval. | OSW Aligner System 3-D software performs the | |
| following operations: | ||
| • Produce 3D-model file of the PVS impression or | ||
| digital scan. | ||
| • Identifies the individual teeth that will require | ||
| treatment (i.e. repositioning). | ||
| • Creates a treatment plan (i.e. 3-D models that | ||
| represent the treatment plan). The treating dental | ||
| practitioner reviews these images using OSWDP | ||
| software and has the option to reject or request | ||
| modifications to the set-up prior to approval. | ||
| Material | Thermoplastic | 0.03" thick, thermoformed polyurethane |
| Appliance Application | Removable | Removable |
| Design | Image: 3D Smile Predict Aligner | Image: OSW Aligner System |
| Biocompatible | Yes | Yes |
| OTC or Rx | Rx | Rx |
| Sterile | Non-sterile | Non-sterile |
The wording of the Indications for Use of the Subject device is slightly different than that of the Predicate device. At this time, the Subject device is indicated for patients with permanent dentition. This does not change the intended use of both Subject and Predicate devices to be used in the alignment of teeth during orthodontic treatment of malocclusion.
5.7 TECHNOLOGICAL CHARACTERISTICS
Orthodontic tooth movement occurs through forces applied to the teeth by the appliance as each tooth follows the predetermined displacement based on a dental health professional's prescription. The Subject device mode of action and method of use are identical to the Predicate device and supports a determination of substantial equivalence.
Even if the specific features or process of the Software used in treatment planning differs, the use of Software in treatment planning supports a determination of substantial equivalence. Most importantly, both verified and validated software programs rely on the prescribing doctor's approval of the treatment plan. The Subject and Predicate devices are both fabricated of a non-sterile, biocompatible thermoplastic material which supports a determination of substantial equivalence.
5.8 PERFORMANCE DATA
Due to the difficulty in evaluating this type of dental device in a laboratory environment, no direct performance bench testing of the aligners was performed. The use of thermoplastic materials for sequential aligners intended to treat malocclusions have been well documented in scientific literature regarding incremental tooth moving forces.
A manufacturing validation was performed to demonstrate the dimensional accuracy of the manufacturing process for 3D Smile Predict Aligners. Three critical aspects of the manufacturing process were assessed for accuracy: 3D printed molds, thermoformed aligner adaptation to the mold, thermoformed aligner to the software output.
Inspection software was used to perform point-to-point and critical displacement measurements.
5
All measurements were within the acceptance criteria. These test have met the pre-established acceptance criteria to demonstrate dimensional accuracy.
An aligner fit validation was performed to confirm fit of aligners on the patient.
5.9 CLINICAL TESTING
The performance of sequential aligners in the clinical environment has been well established since the first such devices were cleared by the FDA in 1998 under product code NXC. There no clinical testing is required to support 3D Smile Predict Aligners, as the Indications for Use is equivalent to the Predicate device, which also was not subject to clinical testing. No clinical data is included in this submission.
5.10 BIOLOGICAL TESTING
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". The results of the tests satisfy the requirements of the study protocols and comply with ISO 10993-1 for the intended use.
The following biological tests were performed:
| Biological Endpoint | Relevant Standard |
|---|---|
| Cytotoxicity | ISO 10993-5:2009 |
| Sensitization | ISO 10993-10:2010 |
| Irritation | ISO 10993-10:2010 |
| Subacute/SubChronic Toxicity | ISO 10993-11:2006 |
| Genotoxicity | ISO 10993-3:2014 |
5.11 CONCLUSION
Overall, the Indications for Use statement for the Subject and Predicate devices are substantially equivalent.
Overall, the Technological Characteristics, Materials, Prescription Use and Non-sterile status of the Subject device are substantially equivalent to the Predicate device. The use of Software to produce the Subject and Predicate devices is substantially equivalent.
Overall, the 3D Smile Predict aligners are substantially equivalent to the Predicate device.