(101 days)
Not Found
No
The description details a standard process for creating dental aligners using scans/impressions, software for treatment planning, 3D printing, and thermoforming. There is no mention of AI or ML being used in any part of this process, including the treatment planning software.
Yes
The device is described as "indicated for use in the alignment of permanent teeth...through orthodontic treatment of misalignment and malocclusion," which clearly describes a therapeutic function.
No
The device, Straight T Clear Dental Aligners, is described as a treatment device for orthodontic issues. It is used to align teeth through continuous force, not to diagnose a condition. While an initial assessment by a dental professional is mentioned, the device itself is a therapeutic tool.
No
The device description clearly outlines the fabrication of physical aligners using thermoforming and 3D printing, which are hardware components. While software is used in the treatment planning process, the final device delivered to the patient is a physical object.
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, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Straight T Clear Dental Aligners are physical devices worn in the mouth to mechanically move teeth. They are fabricated based on physical impressions or scans of the teeth, but they do not analyze biological samples.
- Intended Use: The intended use is for the "alignment of permanent teeth... through orthodontic treatment." This is a mechanical/physical treatment, not a diagnostic process involving biological samples.
The device description clearly outlines a process of creating physical aligners based on anatomical data (scans or impressions) and a treatment plan. There is no mention of analyzing biological specimens for diagnostic purposes.
N/A
Intended Use / Indications for Use
The Straight T Clear Dental Aligners indicated for use in the alignment of permanent teeth (i.e. all second molars) through orthodontic treatment of misalignment and malocclusion.
Product codes (comma separated list FDA assigned to the subject device)
NXC
Device Description
A dental health professional (e.g. orthodontist or dentist) prescribes the Straight T Dental Aligners based on an assessment of the patient's teeth. The dental health professional (dentist/orthodontist) takes intraoral scans or physical impressions of the patient's teeth, determines a course of treatment with the system, and completes a prescription form using a standard dental software used for tooth alignment. Straight T Clear Dental Aligner are intraoral thermoformed plastic aligners that are worn 20 to 21 hours per day and are designed to be used in a sequence, each aligner providing a gentle continuous force, to allow for the movement of teeth to the final desired position. The aligners are to be removed for eating and for cleaning. Straight T Clear Dental Aligners are fabricated using a three-step process.
The first step is to obtain the dimensions and details of the patient's baseline dentition. This is generally done using an oral scan data or a physical impression. This scanned data (digital CAD/CAM models or patient models) are imported into specialized dental software for treatment planning. The second step is the printing of 3D models of the treatment plan for use in step 3 (thermoforming). In the second step, Straight T Dental utilizes a software application to plan the treatment by creating a series of sequential models that gradually position the teeth into their final desired position. The treatment plan is sent to the doctor for approval. Upon approval, a 3D printer is used to create the molds needed for each treatment step to provide the surface around which the aligner is thermoformed. The final step is the thermoforming of a plastic sheet material to each of the sequential treatment steps. This process is done using a standard thermoforming equipment and the appropriate material as outlined in this submission. The trays are provided to the dental health care professional who provides them to the patient in sequential stages, confirming fit and design. The dental health professional monitors treatment from the moment the first aligner is delivered to when the final aligner is finished and treatment is complete.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
intraoral scans or physical impressions
Anatomical Site
permanent teeth
Indicated Patient Age Range
Not Found
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)
Device Testing:
Biocompatibility: Tested according to Good Laboratory Practices for its biocompatibility according to ISO 10993, as follows:
Part 3 (Bacterial Mutagenicity - Ames Assay)
Part 5 (Cytotoxicity Elution - MEM),
Part 10 (Intracutaneous/Intradermal) Reactivity), Part 10 (Oral Mucosa Irritation),
Part 10 (Maximization for Delayed-Type Hypersensitivity),
Part 11 (Subacute Systemic Toxicity)
Animal Human Testing: No animal or human testing were required for this product because it is composed of the same materials and has a similar design and method of manufacture/fabrication in comparison to the predicate device.
Non-Clinical Physical acceptance Properties Testing: Device material tested to the following standards and meet the criteria
Elongation @ Yield (%) ASTM D638
Elongation @ Break (%) ASTM D638
Tensile @ Yield (PSI) ASTM D638
Tensile Strength (PSI) ASTM D638
Tensile Modulus (PSI) ASTM D638
Flexural Modulus (PSI) ASTM D790
Flexural Strength (PSI) ASTM D790
Specific Gravity g.cm3 ASTM D792
Water Absorption (%)24 hours @ 23°C ASTM D570
Gardner Impact Strength 23°C J/mm ASTM D5420
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
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.
September 10, 2020
Straight T, Inc. % Robert Dean President Compliance Systems International, LLC. 1083 Delaware Ave. Buffalo, New York 14209
Re: K201450
Trade/Device Name: Straight T Clear Dental Aligner Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: July 30, 2020 Received: August 4, 2020
Dear Robert Dean:
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
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 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).
Sincerely,
for Srinivas "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
2
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | Form Approved: OMB No. 0910-0120 |
|---|---|
| Food and Drug Administration | Expiration Date: 06/30/2020 |
| See PRA Statement below. |
Indications for Use
| 510(k) Number (if known) | K201450 |
|---|---|
| Device Name | Straight T Clear Dental Aligner |
| Indications for Use (Describe) | The Straight T Clear Dental Aligners indicated for use in the alignment of permanent teeth (i.e. all second molars) through orthodontic treatment of misalignment and 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the
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and review the collection of information. Send comments regarding this burden estimate or any other aspect
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FORM FDA 3881 (7/17)
Page 1 of 1
PSC Publishing Services (301) 443-6740
3
K201450
510K Summary
| Submitter Name: | Straight T, Inc. | Trade Name: | Submission Device | Predicate Device |
|---|---|---|---|---|
| Submitter Address: | 16952 W. Bell Rd #301, Surprise AZ 85374 | Straight T, Inc. | ||
| Clear Dental Aligners | K173784 | |||
| Smylio Invisible Clear Aligners | ||||
| K173785 | ||||
| Phone Number: | (623)474-384 | 510(k) Number | ||
| Contact Person: | Minh Trinh | Manufacturer | Straight T | Smylio |
| Date Prepared: | May 20, 2020 | Classification #, | ||
| Product Code | ||||
| Device Class | 21 CFR 852.5470 | |||
| NXC | ||||
| 2 | 21 CFR 852.5470 | |||
| NXC | ||||
| 2 | ||||
| Device Trade Name: | Straight T Clear Dental Aligner | Intended Use | The Straight T Clear Dental Aligners | |
| indicated for use in the alignment of | ||||
| permanent teeth (i.e. all second molars) | ||||
| through orthodontic treatment of | ||||
| misalignment and malocclusion. | Smylio Invisible Clear Aligners is indicated | |||
| for use in the alignment of permanent | ||||
| teeth through orthodontic treatment of | ||||
| misalignment and malocclusion. | ||||
| Common Name | Aligners, Sequential | Mode of Action | Alignment of teeth by application of | |
| continuous gentle force, by sequential use | ||||
| of preformed plastic trays. | Alignment of teeth by application of | |||
| continuous gentle force, by sequential use | ||||
| of preformed plastic trays. | ||||
| Classification Name | ||||
| Number | ||||
| Product Code | ||||
| Regulatory Class | Orthodontic Plastic Bracket | |||
| 21 CFR 872.5470 | ||||
| NXC | ||||
| 2 | Method of Use | Each preformed plastic tray is worn by | ||
| the patient as prescribed by the dental | ||||
| practitioner, usually a few weeks prior to | ||||
| using the next sequential Aligners tray. | Each preformed plastic tray is worn by | |||
| the patient as prescribed by the dental | ||||
| practitioner, usually a few weeks prior to | ||||
| using the next sequential Aligners tray. | ||||
| Primary Predicate | ||||
| Device: | K173784, Smylio Invisible Clear Aligner | Material | Thin thermoformed | |
| polyurethane | Thin thermoformed | |||
| polyurethane | ||||
| Statement of | ||||
| Indications | ||||
| for Use | The Straight T Clear Dental Aligners indicated for use in the alignment of | |||
| permanent teeth (i.e. all second molars) through orthodontic treatment of | ||||
| misalignment and malocclusion. | Biocompatible | Yes | Yes | |
| Device Description | ||||
| and Summary of | ||||
| Technological | ||||
| Characteristics | A dental health professional (e.g. orthodontist or dentist) prescribes the Straight T | |||
| Dental Aligners based on an assessment of the patient's teeth. The dental health | ||||
| professional (dentist/orthodontist) takes intraoral scans or physical impressions of | ||||
| the patient's teeth, determines a course of treatment with the system, and | ||||
| completes a prescription form using a standard dental software used for tooth | ||||
| alignment. Straight T Clear Dental Aligner are intraoral thermoformed plastic | ||||
| aligners that are worn 20 to 21 hours per day and are designed to be used in a | ||||
| sequence, each aligner providing a gentle continuous force, to allow for the | ||||
| movement of teeth to the final desired position. The aligners are to be removed for | ||||
| eating and for cleaning. Straight T Clear Dental Aligners are fabricated using a | ||||
| three-step process. | ||||
| The first step is to obtain the dimensions and details of the patient's baseline | ||||
| dentition. This is generally done using an oral scan data or a physical impression. | ||||
| This scanned data (digital CAD/CAM models or patient models) are imported into | ||||
| specialized dental software for treatment planning. The second step is the printing | ||||
| of 3D models of the treatment plan for use in step 3 (thermoforming). In the second | ||||
| step, Straight T Dental utilizes a software application to plan the treatment by | ||||
| creating a series of sequential models that gradually position the teeth into their | ||||
| final desired position. The treatment plan is sent to the doctor for approval. Upon | ||||
| approval, a 3D printer is used to create the molds needed for each treatment step | ||||
| to provide the surface around which the aligner is thermoformed. The final step is | ||||
| the thermoforming of a plastic sheet material to each of the sequential treatment | ||||
| steps. This process is done using a standard thermoforming equipment and the | ||||
| appropriate material as outlined in this submission. The trays are provided to the | ||||
| dental health care professional who provides them to the patient in sequential | ||||
| stages, confirming fit and design. The dental health professional monitors treatment | ||||
| from the moment the first aligner is delivered to when the final aligner is finished | ||||
| and treatment is complete. | OTC or Rx | Rx | Rx | |
| Software Use | Yes, 3Shape K180491 | Yes, 3Shape K 152086 | ||
| Sterile | No | No |
4
Differences between Straight T Clear Dental Aligner compared to predicate device
| Straight T Clear Dental Aligner | S & E Effect | Smylio K173784 |
|---|---|---|
| Straight T prepares the treatment plan | ||
| in Step 2 of the manufacturing process | ||
| for subsequent approval by a doctor. | No effect, both treatment plans | |
| are doctor approved. | Smylio K173784 | |
| doctor prepares | ||
| the treatment plan | ||
| Straight T uses 3Shape Software | ||
| K180491 | No effect, 3Shape Software | |
| K180491 is FDA 510K cleared, the | ||
| use/manufacturing process has | ||
| been validated by Straight T | Smylio uses 3Shape | |
| Software K152086 | ||
| Straight T biocompatibility summary | ||
| applied ISO 10993 | ||
| -3, Biological evaluation of medical | ||
| devices — Part 3: Tests for | ||
| genotoxicity, carcinogenicity and | ||
| reproductive toxicity | No effect on biocompatibility. ISO | |
| 7405 directly references the same | ||
| test as conducted using ISO 10993 | ||
| et.al. | Smylio | |
| biocompatibility | ||
| summary | ||
| references ISO | ||
| 7405, Dentistry – | ||
| Evaluation of | ||
| biocompatibility of |
5
| Mechanism of Action | In the same manner as the predicate device, each aligner exerts gentle force to achieve progressive realignment of the teeth until the final correction has been attained. This is based on the treatment plan and proceeds over time. |
|---|---|
| Device Testing | Biocompatibility |
| Contact of the device to the patient's oral tissue requires the Aligners material to be biocompatible. The thermoplastic polyurethane has been tested according to Good Laboratory Practices for its biocompatibility according to ISO 10993, as follows: | |
| Part 3 (Bacterial Mutagenicity - Ames Assay) | |
| Part 5 (Cytotoxicity Elution - MEM), | |
| Part 10 (Intracutaneous/Intradermal) | |
| Reactivity), Part 10 (Oral Mucosa Irritation), | |
| Part 10 (Maximization for Delayed-Type Hypersensitivity), | |
| Part 11 (Subacute Systemic Toxicity) | |
| Animal Human Testing | |
| No animal or human testing were required for this product because it is composed of the same materials and has a similar design and method of manufacture/fabrication in comparison to the predicate device. | |
| Non-Clinical Physical acceptance Properties Testing: | Device material tested to the following standards and meet the criteria |
| Elongation @ Yield (%) ASTM D638Elongation @ Break (%) ASTM D638Tensile @ Yield (PSI) ASTM D638Tensile Strength (PSI) ASTM D638Tensile Modulus (PSI) ASTM D638Flexural Modulus (PSI) ASTM D790Flexural Strength (PSI) ASTM D790Specific Gravity g.cm3 ASTM D792Water Absorption (%)24 hours @ 23°C ASTM D570 |
- Gardner Impact Strength 23°C J/mm ASTM D5420
6
| • -5, Biological evaluation of medical
devices -- Part 5: Tests for in vitro
cytotoxicity | medical devices
used in dentistry |
|---------------------------------------------------------------------------------------------------------------|--------------------------------------|
| • -10, Biological evaluation of medical
devices -- Part 10: Tests for irritation
and skin sensitization | |
| • -11, Biological evaluation of medical
devices -- Part 11: Tests for systemic
toxicity | |
The intended use of the Straight T, Inc. Clear Dental Aligner is the same to that of the primary predicate device as they are both intended for correcting dental malocclusion in patients with permanent dentition.
It has a similar technological principle, and the device characteristics are similar to the predicate device. The mode of operation and the material used to fabricate the aligner trays is the same as the predicate device. There are minor differences comparing Straight T Clear Dental Aligner to the predicate Smylio Invisible Clear Aligners which do not affect substantial equivalence or safety and effectiveness.
Substantial Equivalence Conclusion
Thus, based on the above it can be concluded that Straight T Clear Dental Aligners is substantially equivalent to the predicate device.