(202 days)
Unknown
The description mentions "specialized orthodontic CAD/CAM software" and "treatment simulation," which are common applications where AI/ML could be used, but the summary does not explicitly state that AI/ML is incorporated into the software or the process. The reference to the ArchForm Treatment Planning System (K213916) also doesn't confirm AI/ML use in this summary.
Yes
The device is a STR8 Clear Aligner, indicated for the alignment of teeth during orthodontic treatment of malocclusions, which is considered a therapeutic function.
No.
The device is an aligner used for orthodontic treatment, not for diagnosing a condition. It facilitates the movement of teeth based on a pre-determined treatment plan developed using specialized software.
No
The device description clearly states that the device is "thermoformed plastic aligners" which are physical objects, not software. While software is used in the design process, the final medical device is a physical product.
Based on the provided information, the STR8 Clear Aligner is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens derived from the human body. The STR8 Clear Aligner is a physical device worn in the mouth to move teeth. It does not analyze or test any biological samples.
- The intended use is for the physical alignment of teeth. This is a mechanical process, not a diagnostic one.
- The device description focuses on the manufacturing and use of the physical aligners. While it uses digital scans and software for planning, the device itself is the aligner, which is a therapeutic device.
- The performance testing described is related to the physical properties and manufacturing accuracy of the aligners, not the analysis of biological samples or diagnostic accuracy.
The software used for treatment planning (ArchForm Treatment Planning System) is a separate device with its own 510(k) clearance (K213916) and is classified under a regulation related to orthodontic models and planning, not IVDs.
Therefore, the STR8 Clear Aligner is a medical device (specifically, a dental device for orthodontic treatment), but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The STR8 Clear Aligner is indicated for the alignment of teeth during orthodontic treatment of malocclusions by way of continuous gentle forces.
Product codes
NXC
Device Description
STR8 Clear Aligners are thermoformed plastic aligners designed to be worn in sequence to facilitate the movement to the teeth to the final desired position. The sequential aligners introduce incremental movements that move teeth by way of gentle continuous force. The aligners are to be worn 20 to 22 hours a day and are to be removed for eating and for cleaning.
STR8 Clear Aligners are designed from digital scans of a patient's dentition. Using the scan, specialized orthodontic CAD/CAM software will be used to develop the treatment plans that consist of sequential dental models wherein the teeth are gradually realigned with each step. For this 510(k), ArchForm Treatment Planning System (K213916) will be used for this application. ArchForm is approved for use in the management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual appliance design options. The specialized orthodontic treatment planning software has a 510k clearance for the intended use under FDA Classification Product Code PNN, regulation 872.5470.
Once the treatment plan is reviewed and approved by a STR8 Oral Care dental health professional, each 3D model from the treatment plan is manufactured. The aligner trays are then manufactured by thermoforming a dental thermoplastic sheet over each model. The aligners are then provided to the patient by the prescribing dental professional group.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
digital scans of a patient's dentition
Anatomical Site
teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
prescribing dental professional group
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
Non-Clinical Performance Testing: The use of thermoplastic materials for sequential aligners intended to treat malocclusions has been well documented in scientific literature regarding incremental tooth moving forces. However, durability testing was completed on these aligners. Real world use was simulated to ensure that the aligner material and manufacturing process produced aligners that were suitable for their prescribed period of use.
An internal manufacturing validation was performed to establish the dimensional accuracy of the manufacturing process for the STR8 Clear Aligners. The submitted intraoral scans, digital dentition models, from treatment planning, 3D printed molds and the final thermoformed aligners were all assessed quantitatively in the validation. Thus, the robustness of the process was demonstrated from 3D printing through thermoforming.
All measurements were within 0.3 mm of the target input value, the predefined tolerance of the manufacturing process. Furthermore, throughout the qualitative assessment of the aligners no performance, cosmetic, or other detectable issues were identified. This validation has met the pre-established acceptance criteria to demonstrate that the STR8 manufacturing process yields dimensional accurate products that meet product specifications.
The dental thermoplastic material used for STR8 Clear Aligners is a well-establish and commonly used thermoplastic, Zendura FLX. Biocompatibility testing for the aligner material, the only patient contacting material, was conducted by the manufacturer in accordance with International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".
Additional cytotoxicity testing according to ISO 10993-5:2009 was performed on final manufactured STR8 Clear Aligners.
Clinical Performance Testing: The technical characteristics, indications for use, material, manufacturing, and sterilization processes are the same to the predicate device and therefore, no clinical studies were deemed necessary to demonstrate the safety and effectiveness of the subject device.
Key Metrics
All measurements were within 0.3 mm of the target input value, the predefined tolerance of the manufacturing process.
Predicate Device(s)
uLab Systems Dental Aligner (K211510)
Reference Device(s)
ArchForm Treatment Planning System (K213916)
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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 24, 2023
STR8 Oral Care % Elisabeth Miller Regulatory Affairs Consultant Prime Path Medtech 1321 Upland Dr. Suite 6792 Houston, Texas 77043
Re: K223141
Trade/Device Name: STR8 Clear Aligner Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: February 21, 2023 Received: February 21, 2023
Dear Elisabeth Miller:
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.
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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.
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
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Indications for Use
510(k) Number (if known)
Device Name STR8 Clear Aligners
Indications for Use (Describe)
The STR8 Clear Aligner is indicated for the aligment of teeth during orthodontic treatment of malocclusions by way of continuous gentle forces.
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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Section 5. 510(k) Summary
A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92.
| Submitter: | STR8 Oral Care |
|---|---|
| Company Contact Person: | |
| Address: | |
| Phone: | |
| Email: | Misee Harris |
| 217 E Cherry Ave Jonesboro, AR 72401 | |
| 931-797-1821 | |
| miseeharris@cdcjonesboro.com | |
| Submission Correspondent: | |
| Address: | |
| Phone: | |
| Email: | Elisabeth Miller, Regulatory Affairs Consultant |
| 1321 Upland Dr. Suite 6792 Houston, TX 77043 | |
| (586) 242-7718 | |
| emiller@primepathmedtech.com | |
| Date Prepared: | September 2022 |
| Proprietary Name: | STR8 Clear Aligners |
| Common Name: | Sequential Clear Aligner |
| Product Code: | NXC – Orthodontic plastic bracket |
| Device Classification: | Class II, 21 CFR 872.5470 |
| Predicate Device: | uLab Systems Dental Aligner (K211510) |
| Classification Name: | Aligner, Sequential |
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Device Description:
STR8 Clear Aligners are thermoformed plastic aligners designed to be worn in sequence to facilitate the movement to the teeth to the final desired position. The sequential aligners introduce incremental movements that move teeth by way of gentle continuous force. The aligners are to be worn 20 to 22 hours a day and are to be removed for eating and for cleaning.
STR8 Clear Aligners are designed from digital scans of a patient's dentition. Using the scan, specialized orthodontic CAD/CAM software will be used to develop the treatment plans that consist of sequential dental models wherein the teeth are gradually realigned with each step. For this 510(k), ArchForm Treatment Planning System (K213916) will be used for this application. ArchForm is approved for use in the management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual appliance design options. The specialized orthodontic treatment planning software has a 510k clearance for the intended use under FDA Classification Product Code PNN, regulation 872.5470.
Once the treatment plan is reviewed and approved by a STR8 Oral Care dental health professional, each 3D model from the treatment plan is manufactured. The aligner trays are then manufactured by thermoforming a dental thermoplastic sheet over each model. The aligners are then provided to the patient by the prescribing dental professional group.
Indications for Use:
The STR8 Clear Aligner is indicated for the alignment of teeth during orthodontic treatment of malocclusions by way of continuous gentle forces.
5
Comparison to Predicate Devices:
STR8 Clear Aligners are functionally equivalent to the following predicate device: uLab Systems Dental Aligner Kit (K211510).
| Specification | Subject Device: | Predicate Device: | Comparison Result |
|---|---|---|---|
| STR8 Clear Aligners | uLab Systems Dental Aligner Kit (K211510) | ||
| Regulation Number | 21 CRF 872.5470 | 21 CRF 872.5470 | Same |
| Classification Name | Aligner, Sequential | Aligner, Sequential | Same |
| Product Code | NXC | NXC | Same |
| Classification | Class II | Class II | Same |
| OTC or Rx | Rx | Rx | Same |
| Material | Zendura FLX (copolyester and polyurethane composite) | Zendura A (thin thermoformed polyurethane) or Zendura FLX (copolyester and polyurethane composite) | Similar (Zendura A) or Same (Zendura FLX) |
| Biocompatible | Yes | Yes | Same |
| Sterile | No | No | Same |
| Device Description | A series of customized removable clear plastic orthodontic aligners that sequentially position teeth by way of continuous gentle force. | A series of customized removable clear plastic orthodontic aligners that sequentially position teeth by way of continuous gentle force. | Same |
| Patient Removable? | Yes | Yes | Same |
| Indication for Use | The STR8 Clear Aligner is indicated for the alignment of teeth during | The uLab Systems Dental Aligner is indicated for the alignment of teeth during | Same |
| orthodontic treatment of | |||
| malocclusions by way of | |||
| continuous gentle forces. | orthodontic treatment of | ||
| malocclusions by way of | |||
| continuous gentle forces. | |||
| Intended Use | Orthodontic Tooth | ||
| Movement | Orthodontic Tooth | ||
| Movement | Same | ||
| Principles of | |||
| Operation | Each preformed plastic | ||
| tray is worn in sequence | |||
| by the patient as | |||
| prescribed by the dental | |||
| practitioner. Orthodontic | |||
| movement occurs through | |||
| continuous gentle forces | |||
| applied to the dentition as | |||
| each tooth follows the | |||
| programmed | |||
| displacement based on | |||
| the doctor's prescription. | Each preformed plastic | ||
| tray is worn in sequence | |||
| by the patient as | |||
| prescribed by the dental | |||
| practitioner. Orthodontic | |||
| movement occurs through | |||
| continuous gentle forces | |||
| applied to the dentition as | |||
| each tooth follows the | |||
| programmed | |||
| displacement based on | |||
| the doctor's prescription. | Same | ||
| Aligner Design | |||
| Process | Standard dental software | ||
| for tooth alignment uses | |||
| digital scan (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 for | |||
| aligner fabrication. Once | |||
| the dental practitioner | |||
| approves the treatment | |||
| plan, the software | |||
| converts the files to | |||
| produce a series 3D | |||
| models used to produce | |||
| thermoformed aligners. | Standard dental software, | ||
| including the uLab | |||
| Systems uDesign. | |||
| K171295, for tooth | |||
| alignment uses digital | |||
| scan (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, make 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 3D | |||
| models used to produce | |||
| thermoformed aligners. | Same |
Table 1. Predicate Device Comparison
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7
Comparison for Indications for the Use to Predicate Device:
Based on the above comparison, the indications for use of the STR8 Clear Aligners in this submission is the same as the uLab Systems Dental Aligner Kit (K211510) as they are both indicated for the alignment of teeth during orthodontic treatment of malocclusions by way of continuous gentle forces. Thus, the STR8 Clear Aligners can be considered substantially equivalent to its predicate device.
Comparison of Technical Characteristics to Predicate Device
Based on the above comparison, the design, construction, and performance characteristics of the STR8 Clear Aligners is similar to that of the uLAB Systems Dental Aligner Kit (K211510).
The only difference between the subject device (STR8 Clear Aligner) and predicate device (uLab Systems Dental Aligner Kit) is the material differences come from the additional material (Zendura A) used for the predicate device. The expansion of material does not increase the risk associated with manufacturing, and the subject device and predicate device do share an exact material, Zendura FLX.
Thus, the STR8 Clear Aligners can be considered substantially equivalent to its predicate device.
Non-Clinical Performance Testing
The use of thermoplastic materials for sequential aligners intended to treat malocclusions has been well documented in scientific literature regarding incremental tooth moving forces. However, durability testing was completed on these aligners. Real world use was simulated to ensure that the aligner material and manufacturing process produced aligners that were suitable for their prescribed period of use.
An internal manufacturing validation was performed to establish the dimensional accuracy of the manufacturing process for the STR8 Clear Aligners. The submitted intraoral scans, digital dentition models, from treatment planning, 3D printed molds and the final thermoformed aligners were all assessed quantitatively in the validation. Thus, the robustness of the process was demonstrated from 3D printing through thermoforming.
All measurements were within 0.3 mm of the target input value, the predefined tolerance of the manufacturing process. Furthermore, throughout the qualitative assessment of the aligners no performance, cosmetic, or other detectable issues were identified. This validation has met the pre-established acceptance criteria to demonstrate that the STR8 manufacturing process yields dimensional accurate products that meet product specifications.
The dental thermoplastic material used for STR8 Clear Aligners is a well-establish and commonly used thermoplastic, Zendura FLX. Biocompatibility testing for the aligner
8
material, the only patient contacting material, was conducted by the manufacturer in accordance with International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".
Additional cytotoxicity testing according to ISO 10993-5:2009 was performed on final manufactured STR8 Clear Aligners.
Clinical Performance Testing
The technical characteristics, indications for use, material, manufacturing, and sterilization processes are the same to the predicate device and therefore, no clinical studies were deemed necessary to demonstrate the safety and effectiveness of the subject device.
Conclusion
Based on the similarities in indications for use, technological characteristics, and materials the STR8 Clear Aligners are substantially equivalent to the uLab Systems Dental Aligner Kit (K211510)