(103 days)
Not Found
No
The summary describes a physical dental aligner system and its material properties and performance testing, with no mention of AI or ML in the device description, intended use, or performance studies.
Yes.
The device is indicated for "orthodontic treatment of malocclusions by way of continuous gentle forces" to align teeth, which directly addresses a medical condition (malocclusion) through physical intervention.
No.
The device is an orthodontic treatment system designed for alignment of teeth, not for diagnosing medical conditions. It uses physical forces to move teeth, which is a therapeutic action, not a diagnostic one.
No
The device description explicitly states it is a "clear aligner system fabricated using the commercially available Zendura FLX," which is a physical material. The performance studies also focus on the physical properties of this material. This indicates a hardware component, not a software-only device.
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 derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The MyClearALIGN Dental Aligner System is a physical device used to apply forces to teeth for orthodontic treatment. It directly interacts with the patient's anatomy.
- Intended Use: The intended use is for the "alignment of all permanent teeth/full permanent dentition during orthodontic treatment of malocclusions." This is a therapeutic and mechanical function, not a diagnostic one based on analyzing biological specimens.
- Input: The input is "digital scans of the patient's teeth," which are anatomical measurements, not biological specimens.
Therefore, the MyClearALIGN Dental Aligner System falls under the category of a medical device used for treatment, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The MyClearALIGN Dental Aligner System is indicated for the alignment of all permanent teeth/full permanent dentition during orthodontic treatment of malocclusions by way of continuous gentle forces.
Product codes
NXC
Device Description
MyClearALIGN Dental Aligner System device is a clear aligner system fabricated using the commercially available Zendura FLX, a clear, thin thermoformed Copolyester – Polyurethane Composite with 2 outer layers of cycloaliphatic polyester and an inner layer of polyether polyurethane. The pressure areas create forces that combine to form couples and thus a moment around or near the center of resistance or center of rotation of the tooth. A series of aligners is fabricated to sequentially move the teeth from their original positions of better alignment. Each set of aligners is designed to be replaced after approximately 2 weeks of 20-22 hours of wear per day (Approximately 300 hours per aligner). Each tooth is moved no greater than 0.25mm in one aligner stage (approximately 2 weeks of 20-22 hours of wear per day).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
digital scans
Anatomical Site
permanent teeth/full permanent dentition
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
A series of studies were completed to demonstrate the substantial equivalence of MyClearALIGN Dental Aligner System to the predicate device. All testing was conducted in accordance with and in conformance to applicable device regulations and guidance. Results of all testing demonstrate the device is non-toxic, is comparable to other currently marketed devices and is substantially equivalent to legally marketed predicate and included:
Biocompatibility
• ISO 1093-3:2014, biological evaluation of medical devices – part 3: tests for genotoxicity and reproductive toxicity.
• ISO 10993-5:2009, biological evaluation of medical devices -- part 5: tests for in vitro cytotoxicity.
• ISO 10993-10 : 2010, biological evaluation of medical devices - part 10: tests for irritation and skin sensitization. (Biocompatibility).
• ISO 10993-11 Third edition 2017-09 biological evaluation of medical devices part 11: Tests for systemic toxicity
Performance Testing Bench
The following Bench testing was performed:
• FLX E2 Zendura XL Design Verification Report_TROUSER TEAR_#18-14 Rev 1
• FLX E3 Zendura XL Design Verification Report Light Transmission and Haze #18-10 Rev 1
• FLX E4 Zendura XL Thermoforming Verification Report #18-15 Rev 1
• FLX E17 Zendura XL Report Compatible with Commercial Denture Disinfectant #17-31
• FLX E18 Zendura XL Report Exposure to Common Beverages #17-022
• FLX E19 Zendura XL Report Extended 37C Saline Exposure #17-33
• FLX E20 Zendura XL Report Extended 47C Saline Exposure 17-26
• FLX E21 Zendura XL Report Outdoor Exposure Effects#17-024
• Zendura FLX Stain _25Jan2018
• Zendura XL Design Verification Report Flexural Properties #17-44 Rev 1
• Zendura XL Design Verification Report Tensile&Elongation #17-46 Rev 1
• Zendura XL Design Verification Report- Stain Resistance #18-05 Rev1
• Zendura XL Design Verification Report- Stress Relaxation #18-24 Rev 1
Performance Testing Clinical
There were no clinical studies performed.
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 logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 31, 2022
Key Dental Technologies, LLC % Thomas Padula Vice President of Regulatory Compliance Schiff & Company, Inc. 583 Mountain Avenue North Caldwell, New Jersey 07006
Re: K221475
Trade/Device Name: MyClearALIGN Dental Aligner System Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: May 19, 2022 Received: July 19, 2022
Dear Thomas Padula:
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, 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 Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Submission Number (if known)
Device Name
MyClearALIGN Dental Aligner System
Indications for Use (Describe)
The MyClearALIGN Dental Aligner System is indicated for the alignment of all permanent teeth/full permanent dentition during orthodontic treatment of may 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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| 510(k) #: | K221475 | 510(k) Summary | Prepared on: 2022-07-18 |
|---|---|---|---|
| Contact Details | 21 CFR 807.92(a)(1) | ||
| Applicant Name | Key Dental Technologies, LLC | ||
| Applicant Address | 920 MLK Blvd Suite 920-B Chapel Hill NC 27517 United States | ||
| Applicant Contact Telephone | 919-259-2280 | ||
| Applicant Contact | Dr. Larry Moray | ||
| Applicant Contact Email | dr.larrymoray@myorthodontistus.com | ||
| Correspondent Name | Schiff & Company, Inc. | ||
| Correspondent Address | 583 Mountain Avenue North Caldwell NJ 07006 United States | ||
| Correspondent Contact Telephone | 201-317-8810 | ||
| Correspondent Contact | Mr. Thomas Padula | ||
| Correspondent Contact Email | thomaspadula@schiffandcompany.com | ||
| Device Name | 21 CFR 807.92(a)(2) | ||
| Device Trade Name | MyClearALIGN Dental Aligner System | ||
| Common Name | Orthodontic plastic bracket | ||
| Classification Name | Aligner, Sequential | ||
| Regulation Number | 872.5470 | ||
| Product Code | NXC | ||
| Legally Marketed Predicate Devices | |||
| 21 CFR 807.92(a)(3) | |||
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code | |
| K192596 | ULab Systems Dental Aligner Kit | NXC | |
| Device Description Summary | 21 CFR 807.92(a)(4) | ||
| MyClearALIGN Dental Aligner System device is a clear aligner system fabricated using the commercially available Zendura FLX, a clear, | |||
| thin thermoformed Copolyester – Polyurethane Composite with 2 outer layers of cycloaliphatic polyester and an inner layer of polyether | |||
| polyurethane. The pressure areas create forces that combine to form couples and thus a moment around or near the center of resistance | |||
| or center of rotation of the tooth. A series of aligners is fabricated to sequentially move the teeth from their original positions | |||
| of better alignment. Each set of aligners is designed to be replaced after | |||
| approximately 2 weeks of 20-22 hours of wear per day (Approximately 300 hours per aligner). Each tooth is moved no greater than | |||
| 0.25mm in one aligner stage (approximately 2 weeks of 20-22 hours of wear per day). | |||
| Intended Use/Indications for Use | 21 CFR 807.92(a)(5) |
The MyClearALIGN Dental Aligner System is indicated for the alignment teeth/full permanent dentition during
4
orthodontic treatment of malocclusions by way of continuous gentle forces.
Indications for Use Comparison
The indications for use are the same as the predicate device.
Technological Comparison
The subject and predicate device are based on the following same technological elements:
· Both devices are clear plastic sequential aligners.
· Both devices have the same intended use for alignment of teeth during orthodontic treatment of malocclusions by way of continuous gentle forces.
· Both devices have the same indications for use.
· Both devices have the same principle of operation.
- · Both devices are fabricated based on an orthodontic treatment plan designer manufacturer's technicians from digital
- scans of the patient's teeth in an untreated state.
- · Both devices are made of thermoplastic (Zendura-FLX).
MyClearALIGN Dental Aligner System is substantially equivalent in terms of the technological characteristics, features, specifications, materials, mode of operation and indications for use, to ul ab Systems Dental Aligner K192596, cleared for marketing under 510(K).
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
A series of studies were completed to demonstrate the substantial equivalence of MyClearALIGN Dental Aligner System to the predicate device. All testing was conducted in accordance with and in conformance to applicable device regulations and guidance. Results of all testing demonstrate the device is non-toxic, is comparable to other currently marketed devices and is substantially equivalent to legally marketed predicate and included:
Biocompatibility
• ISO 1093-3:2014, biological evaluation of medical devices – part 3: tests for genotoxicity and reproductive toxicity.
· ISO 10993-5:2009, biological evaluation of medical devices -- part 5: tests for in vitro cytotoxicity.
· ISO 10993-10 : 2010, biological evaluation of medical devices - part 10: tests for irritation and skin sensitization. (Biocompatibility).
• ISO 10993-11 Third edition 2017-09 biological evaluation of medical devices part 11: Tests for systemic toxicity
Performance Testing Bench
The following Bench testing was performed:
· FLX E2 Zendura XL Design Verification Report_TROUSER TEAR_#18-14 Rev 1
- FLX E3 Zendura XL Design Verification Report Light Transmission and Haze #18-10 Rev 1
- · FLX E4 Zendura XL Thermoforming Verification Report #18-15 Rev 1
- · FLX E17 Zendura XL Report Compatible with Commercial Denture Disinfectant #17-31
- · FLX E18 Zendura XL Report Exposure to Common Beverages #17-022
- FLX E19 Zendura XL Report Extended 37C Saline Exposure #17-33
- FLX E20 Zendura XL Report Extended 47C Saline Exposure 17-26
- · FLX E21 Zendura XL Report Outdoor Exposure Effects#17-024
- Zendura FLX Stain _25Jan2018
- · Zendura XL Design Verification Report Flexural Properties #17-44 Rev 1
- Zendura XL Design Verification Report Tensile&Elongation #17-46 Rev 1
- · Zendura XL Design Verification Report- Stain Resistance #18-05 Rev1
- Zendura XL Design Verification Report- Stress Relaxation #18-24 Rev 1
Performance Testing Clinical There were no clinical studies performed.
MyClearALIGN Dental Aligner System has the same indications for use and technology characteristics as the predicate device. MyClearALIGN Dental Aligner System is as safe, as effective, and performs as well as the predicate device.