(101 days)
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.
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.
The provided text describes a 510(k) summary for the Straight T Clear Dental Aligner, focusing on demonstrating substantial equivalence to a predicate device (Smylio Invisible Clear Aligners K173784). It primarily presents non-clinical testing for material properties and biocompatibility rather than a study on device performance in terms of its intended use (teeth alignment).
Therefore, there is no information in the provided text to answer most of the questions regarding device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance. The device itself is a physical aligner, not an AI or imaging device, so many of these questions are not applicable in this context.
However, I can extract the acceptance criteria for material properties and the type of ground truth used for biocompatibility.
Here's a breakdown of what can be answered from the provided text:
1. A table of acceptance criteria and the reported device performance
The document lists physical and biocompatibility tests. For physical properties, the acceptance criteria are not explicitly stated as numerical targets but rather that the material "meet the criteria" of the listed ASTM standards. For biocompatibility, the acceptance criteria are implicit in passing the ISO 10993 tests.
| Test Category | Test | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | Part 3 (Bacterial Mutagenicity) | Pass (non-mutagenic) | Passed |
| Part 5 (Cytotoxicity Elution) | Pass (non-cytotoxic) | Passed | |
| Part 10 (Intracutaneous Reactivity) | Pass (non-irritating) | Passed | |
| Part 10 (Oral Mucosa Irritation) | Pass (non-irritating) | Passed | |
| Part 10 (Maximization for Delayed-Type Hypersensitivity) | Pass (non-sensitizing) | Passed | |
| Part 11 (Subacute Systemic Toxicity) | Pass (non-toxic) | Passed | |
| Physical Properties | Elongation @ Yield (%) ASTM D638 | Meet ASTM D638 criteria | Met criteria |
| Elongation @ Break (%) ASTM D638 | Meet ASTM D638 criteria | Met criteria | |
| Tensile @ Yield (PSI) ASTM D638 | Meet ASTM D638 criteria | Met criteria | |
| Tensile Strength (PSI) ASTM D638 | Meet ASTM D638 criteria | Met criteria | |
| Tensile Modulus (PSI) ASTM D638 | Meet ASTM D638 criteria | Met criteria | |
| Flexural Modulus (PSI) ASTM D790 | Meet ASTM D790 criteria | Met criteria | |
| Flexural Strength (PSI) ASTM D790 | Meet ASTM D790 criteria | Met criteria | |
| Specific Gravity g.cm3 ASTM D792 | Meet ASTM D792 criteria | Met criteria | |
| Water Absorption (%) 24 hrs @ 23°C ASTM D570 | Meet ASTM D570 criteria | Met criteria | |
| Gardner Impact Strength 23°C J/mm ASTM D5420 | Meet ASTM D5420 criteria | Met criteria |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify sample sizes for the physical or biocompatibility tests. It also does not provide information on data provenance (country, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. The tests performed are laboratory tests for material properties and biocompatibility, not clinical studies requiring expert ground truth for outcome assessment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study requiring adjudication of clinical outcomes.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a physical dental aligner, not an AI-assisted diagnostic or imaging system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical dental aligner, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For biocompatibility testing, the "ground truth" is established by the standardized methods and results of the ISO 10993 tests themselves, which determine toxicity, mutagenicity, irritation, etc. These are objective laboratory measurements against established biological standards.
For physical properties, the "ground truth" is the measured values of the material properties as determined by the specified ASTM standards. These are objective, quantifiable measurements.
8. The sample size for the training set
Not applicable. This is a physical device, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable. See point 8.
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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
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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
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| DEPARTMENT OF HEALTH AND HUMAN SERVICES | Form Approved: OMB No. 0910-0120 |
|---|---|
| Food and Drug Administration | Expiration Date: 06/30/2020See 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) |
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FORM FDA 3881 (7/17)
Page 1 of 1
PSC Publishing Services (301) 443-6740
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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 | K173784Smylio Invisible Clear AlignersK173785 | |
| Phone Number: | (623)474-384 | 510(k) Number | ||
| Contact Person: | Minh Trinh | Manufacturer | Straight T | Smylio |
| Date Prepared: | May 20, 2020 | Classification #,Product CodeDevice Class | 21 CFR 852.5470NXC2 | 21 CFR 852.5470NXC2 |
| Device Trade Name: | Straight T Clear Dental Aligner | Intended Use | The Straight T Clear Dental Alignersindicated for use in the alignment ofpermanent teeth (i.e. all second molars)through orthodontic treatment ofmisalignment and malocclusion. | Smylio Invisible Clear Aligners is indicatedfor use in the alignment of permanentteeth through orthodontic treatment ofmisalignment and malocclusion. |
| Common Name | Aligners, Sequential | Mode of Action | Alignment of teeth by application ofcontinuous gentle force, by sequential useof preformed plastic trays. | Alignment of teeth by application ofcontinuous gentle force, by sequential useof preformed plastic trays. |
| Classification NameNumberProduct CodeRegulatory Class | Orthodontic Plastic Bracket21 CFR 872.5470NXC2 | Method of Use | Each preformed plastic tray is worn bythe patient as prescribed by the dentalpractitioner, usually a few weeks prior tousing the next sequential Aligners tray. | Each preformed plastic tray is worn bythe patient as prescribed by the dentalpractitioner, usually a few weeks prior tousing the next sequential Aligners tray. |
| Primary PredicateDevice: | K173784, Smylio Invisible Clear Aligner | Material | Thin thermoformedpolyurethane | Thin thermoformedpolyurethane |
| Statement ofIndicationsfor Use | The Straight T Clear Dental Aligners indicated for use in the alignment ofpermanent teeth (i.e. all second molars) through orthodontic treatment ofmisalignment and malocclusion. | Biocompatible | Yes | Yes |
| Device Descriptionand Summary ofTechnologicalCharacteristics | A dental health professional (e.g. orthodontist or dentist) prescribes the Straight TDental Aligners based on an assessment of the patient's teeth. The dental healthprofessional (dentist/orthodontist) takes intraoral scans or physical impressions ofthe patient's teeth, determines a course of treatment with the system, andcompletes a prescription form using a standard dental software used for toothalignment. Straight T Clear Dental Aligner are intraoral thermoformed plasticaligners that are worn 20 to 21 hours per day and are designed to be used in asequence, each aligner providing a gentle continuous force, to allow for themovement of teeth to the final desired position. The aligners are to be removed foreating and for cleaning. Straight T Clear Dental Aligners are fabricated using athree-step process.The first step is to obtain the dimensions and details of the patient's baselinedentition. 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 intospecialized dental software for treatment planning. The second step is the printingof 3D models of the treatment plan for use in step 3 (thermoforming). In the secondstep, Straight T Dental utilizes a software application to plan the treatment bycreating a series of sequential models that gradually position the teeth into theirfinal desired position. The treatment plan is sent to the doctor for approval. Uponapproval, a 3D printer is used to create the molds needed for each treatment stepto provide the surface around which the aligner is thermoformed. The final step isthe thermoforming of a plastic sheet material to each of the sequential treatmentsteps. This process is done using a standard thermoforming equipment and theappropriate material as outlined in this submission. The trays are provided to thedental health care professional who provides them to the patient in sequentialstages, confirming fit and design. The dental health professional monitors treatmentfrom the moment the first aligner is delivered to when the final aligner is finishedand treatment is complete. | OTC or Rx | Rx | Rx |
| Software Use | Yes, 3Shape K180491 | Yes, 3Shape K 152086 | ||
| Sterile | No | No |
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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 planin Step 2 of the manufacturing processfor subsequent approval by a doctor. | No effect, both treatment plansare doctor approved. | Smylio K173784doctor preparesthe treatment plan |
| Straight T uses 3Shape SoftwareK180491 | No effect, 3Shape SoftwareK180491 is FDA 510K cleared, theuse/manufacturing process hasbeen validated by Straight T | Smylio uses 3ShapeSoftware K152086 |
| Straight T biocompatibility summaryapplied ISO 10993-3, Biological evaluation of medicaldevices — Part 3: Tests forgenotoxicity, carcinogenicity andreproductive toxicity | No effect on biocompatibility. ISO7405 directly references the sametest as conducted using ISO 10993et.al. | Smyliobiocompatibilitysummaryreferences ISO7405, Dentistry –Evaluation ofbiocompatibility of |
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| 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
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| • -5, Biological evaluation of medicaldevices -- Part 5: Tests for in vitrocytotoxicity | medical devicesused in dentistry |
|---|---|
| • -10, Biological evaluation of medicaldevices -- Part 10: Tests for irritationand skin sensitization | |
| • -11, Biological evaluation of medicaldevices -- Part 11: Tests for systemictoxicity |
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.
§ 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.