MEM Clear Aligner System

{0} FDA U.S. FOOD & DRUG ADMINISTRATION May 21, 2025 MEM Dental Technology Co., Ltd. % Roger Chen Director LeadTheWay International Corp. 2F., No. 183, Zhouzi St. NeiHu Dist. Taipei City, 11493 TAIWAN Re: K242637 Trade/Device Name: MEM Clear Aligner System Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: September 3, 2024 Received: September 3, 2024 Dear Roger Chen: 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 (the 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 available 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. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K242637 - Roger Chen Page 2 Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory- {2} K242637 - Roger Chen Page 3 assistance/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, MChE, RAC, CQIA 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 {3} DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. Submission Number (if known) K242637 Device Name MEM Clear Aligner System Indications for Use (Describe) MEM Clear Aligner System is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e.all second molars). The MEM Clear Aligner System repositions teeth by way of continuous gentle force. 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 time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4} MEM Dental Technology Co., Ltd. Traditional 510(k) Premarket Submission MEM Clear Aligner System K242637 510(k) Summary A. Submission Submitter Company Name MEM Dental Technology Co., Ltd. Address 2F., No. 22, Lane 31, Sec. 1, Huandong Rd., Southern Taiwan Science Park, Xinshi Dist., Tainan City 74146, Taiwan Contact person Maggie Wei Contact number 886-6-505-3939 Contact email info@memdental.com B. Submission Correspondent Company Name LeadTheWay International Corp. Address 2F., No. 183, Zhouzi St. NeiHu Dist., Taipei City 11493 Taiwan Contact person Roger Chen Contact number 886-2-2627-5779 Contact email roger.chen@leadtheway.co C. Device Information Trade /Device name MEM Clear Aligner System Common name MEM Clear Aligner System Classification Information 21 CFR 872.5470 Orthodontic plastic bracket Class II Product code NXC Predicate device ULab Systems Dental Aligner Kit, K192596 Date Prepared April 10, 2024 {5} MEM Dental Technology Co., Ltd. Traditional 510(k) Premarket Submission MEM Clear Aligner System ## D. Device Description The MEM Clear Aligner System is a customized plastic orthodontic system, consisting of a series of transparent, removable aligners prescribed by a doctor to correct misaligned or crooked teeth. These customized, removable transparent plastic aligners gradually reposition teeth with continuous gentle pressure. The product is a series of transparent, removable orthodontic aligners, custom-made according to the dentist's prescription and designed using the "3Shape A/S (K171634)" software. They are manufactured using thermoforming technology. These aligners are designed to provide a comfortable teeth straightening experience and achieve optimal correction through precise design using advanced technology. ## E. Indications for use MEM Clear Aligner System is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). The MEM Clear Aligner System repositions teeth by way of continuous gentle force. ## F. Substantial equivalence comparison with predicate device Detailed substantial comparison was made between subject device and predicate device. Please refer to below tables for details. {6} MEM Dental Technology Co., Ltd. Traditional 510(k) Premarket Submission MEM Clear Aligner System Table F-1. A COMPARISON TABLE WITH PREDICATE DEVICES | ITEMS | Proposed Device MEM Clear Aligner System | Primary Predicate Device ULab Systems Dental Aligner Kit | Substantial Equivalence Comparison Assessment | | --- | --- | --- | --- | | 510(K)Number | K242637 | K192596 | N/A | | Product Code | NXC | NXC | Same | | Device Classification | Class II | Class II | Same | | Intended Use/Indication(s) for Use | MEM Clear Aligner System is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). The MEM Clear Aligner System repositions teeth by way of continuous gentle force. | The uLab Systems Dental Aligner is indicated for the alignment of permanent teeth during orthodontic treatment of malocclusions by way of continuous gentle forces. | Same | | Mode of Action | Alignment of teeth by application of continuous gentle force, by sequential use of preformed plastic trays. | 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 a doctor's prescription. | 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 a 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 a doctor's prescription. | Same | | 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 aligner tray. | During the orthodontic treatment, each preformed plastic aligner is worn in sequence by the patient as prescribed by the dental practitioner, moving the patient's teeth gradually to the ideal position. | Same | | OTC/Rx | Rx | Rx | Same | | Duration of Use | Each set of aligners can be worn for approximately 2 weeks of 20-22 hours of wear per day or according to doctor's prescription. | Each set of aligners can be worn for approximately 2 weeks of 20-22 hours of wear per day or according to doctor's prescription. | Same | | Method of Manufacturing | Thermoforming | Thermoforming | Same | | Material | Thermoplastic Polymer | thin thermoformed polyurethane copolyester or polyurethane composite | Same | {7} MEM Dental Technology Co., Ltd. Traditional 510(k) Premarket Submission MEM Clear Aligner System | ITEMS | Proposed Device MEM Clear Aligner System | Primary Predicate Device ULab Systems Dental Aligner Kit | Substantial Equivalence Comparison Assessment | | --- | --- | --- | --- | | Design | | | Same | | Application | Removable | Removable | Same | | Biocompatibility | ISO 10993-5 In Vitro Cytotoxicity Test ISO 10993-3 In Vitro Mammalian Cell Gene Mutation Test Using Mouse Lymphoma (L5178Y) Cells ISO 10993-3 In Vivo Mammalian Erythrocyte Micronucleus Test in Mice ISO 10993-23 Oral Mucosa Irritation Study ISO 10993-11 Subacute Systemic Toxicity Study in Rats | Raw materials: Cytotoxicity Elution -MEM Intracutaneous/Intradermal Reactivity Maximization for Delayed-Type Hypersensitivity Oral Mucosa Irritation Test Final product: Cytotoxicity Elution -MEM | Similar | 4 {8} MEM Dental Technology Co., Ltd. Traditional 510(k) Premarket Submission MEM Clear Aligner System Table F-2. Substantial Equivalence Comparison_Table-Predicate Devices-Mechanical Properties | ITEMS | Proposed Device MEM Clear Aligner System | Primary Predicate Device ULab Systems Dental Aligner Kit | Substantial Equivalence Comparison Assessment | | --- | --- | --- | --- | | Ultimate Flexural Strength | 50~110 Mpa (ISO 20795-2:2013) | N/A | According to the evaluation of mechanical properties (safety) of dental materials, the materials are affected by the stress caused by chewing in the mouth; Each dental material responds to this stress in different ways, and may be deformed in some cases. For example, when biting hard food, the corrective device may fall off or break. The larger the value, the better the mechanical properties, and it is not easy to deform or break. | | Flexural Modulus | 1500~1950 Mpa (ISO 20795-2:2013) | N/A | Similar | | Shore D Hardness | ≥40 Hd | N/A | Similar | | Water Sorption | 0.43~0.58% (ASTM D570) | 0.10-0.25% (ASTM D570) | The safety evaluation of equipment, the high moisture content of plastic will directly affect the mechanical strength/external surface/size performance of the equipment. Especially for the shapes of related materials, the water absorption rate should be taken into consideration, and the difference should not be too large. | {9} MEM Dental Technology Co., Ltd. Traditional 510(k) Premarket Submission MEM Clear Aligner System ## G. Non-Clinical Performance Data The following performance data were provided to demonstrate the safety and efficacy, and all the results meet the product specification requirements. - ISO 10993-3:2014 Genotoxicity Test - ISO 10993-5:2009 In vitro Cytotoxicity Test - ISO 10993-6:2016 Subcutaneous Implantation Test - ISO 10993-10:2010 Skin Irritation Test - ISO 10993-10:2010 Skin Sensitization Test - ISO 10993-11:2017 Acute Systemic Toxicity Test - ISO 10993-11:2017 Subacute Systemic Toxicity Test - ISO 10993-11:2017 Pyrogenicity Test - ISO 10993-12:2021 Extract Test - ISO 10993-23:2021 Oral Mucosa Irritation Test - Transportation, packaging and shelf-life testing were validated and completed. - Physical properties testing has been completed and provided. - Design verification, validation and manufacturing validation were completed. ## H. Conclusion (Substantial Equivalence Conclusions) The MEM Clear Aligner System has the same intended use as predicate device. It also shares similar technological characteristics. Performance data shows that any differences in these characteristics do not raise new safety or effectiveness concerns. Therefore, we conclude that the MEM Clear Aligner System is substantially equivalent to the predicate device.