ClearCorrect System

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows 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, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in large, bold, blue letters, and the word "ADMINISTRATION" in smaller, blue letters below. August 6, 2021 Christopher Klaczyk, VP, Head of Regulatory Affairs ClearCorrect LLC 21 Cypress Boulevard, Suite 1010 Round Rock, TX 78665 USA Re: K210320 Trade/Device Name: ClearCorrect System Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: May 3, 2021 Received: May 5, 2021 Dear Christopher Klaczyk: 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's {1}------------------------------------------------ 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 (OS) 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 {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K210320 Device Name ClearCorrect System Indications for Use (Describe) The ClearCorrect System is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). The ClearCorrect System positions teeth by way of continuous gentle force. Type of Use (Select one or both, as applicable) X 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." {3}------------------------------------------------ | 5. | 510(k) Summary | K210320 | |----|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Submitter: | ClearCorrect, LLC<br>21 Cypress Boulevard<br>Suite 1010<br>Round Rock, TX 78665 | | | Contact Person: | Christopher Klaczyk<br>Head of Regulatory Affairs<br>+1 (512) 831-5128<br>christopher.klaczyk@clearcorrect.com | | | Date Prepared: | July 30, 2021 | | | Product Code(s): | NXC (21 CFR 872.5470) | | | Device Class: | II (21 CFR 872.5470) | | | Classification Panel: | Dental Devices (DHT1B) | | | Classification Name: | Orthodontic plastic bracket (21 CFR 872.5470) | | | Common Name | Aligner, Sequential | | | Proprietary Name: | ClearCorrect System | | | Predicate Device(s): | K113618, ClearCorrect System, ClearCorrect LLC | | | Reference Device(s): | K182826, Ormco™ Spark™ Aligner System, Sybron Dental<br>Specialties | | | Device Description: | The aligners of the ClearCorrect System are a sequential<br>series of clear thermoformed orthodontic appliances that,<br>when worn in the prescribed sequence and duration,<br>progressively reposition the teeth. The aligner is an<br>orthodontic appliance intended for intra-oral use. Individual<br>devices will be used between 20 – 22 hours per day for a<br>period ranging from one to three weeks The corrective force<br>to align teeth are primarily generated by the difference<br>between the starting tooth position and the planned tooth<br>position defined by the tray. Features can be added to the<br>aligner that engage with composite resin tooth attachments to<br>improve aligner retention and/or to apply force in directions<br>that cannot be achieved by engaging with tooth surfaces | {4}------------------------------------------------ The retainers of the ClearCorrect System are clear thermoformed appliances intended to keep the teeth from relapsing after they have been treated with aligners. Retainers are an optional component of aligner therapy. Retainers are typically prescribed for use at the conclusion of aligner treatment but can be prescribed at other times should there be a need to interrupt aligner treatment. The engager templates of the ClearCorrect System are clear thermoformed appliances used to accurately apply composite resin attachments to the teeth as needed to achieve the desired tooth movement. The use of engagers and engager templates is an optional component of aligner treatment. Cavities are formed in the film having the desired shape, orientation and tooth position of the engager attachments to be bonded to the patient's teeth. At the time of use, the clinician fills the cavities in the engager template with light-curing composite resin. The engager template is then placed onto the patient's teeth and the resin cured. Once the resin is cured, the engager template is removed and discarded. Image /page/4/Picture/3 description: The image shows a clear aligner on a pink background. The aligner is a dental device used to straighten teeth. It is made of clear plastic and is designed to fit over the teeth. The aligner is custom-made for each patient and is worn for a specific period of time. The pink background is a solid color and provides a contrast to the clear aligner. Picture of Device Indications For Use: Materials: The ClearCorrect aligners are produced from multi-laver polymer film having the trade name ClearQuartz™. The film consists of one laver of elastomeric polyurethane sandwiched between two-layers of rigid co-polyester. The ClearCorrect System is indicated for the treatment of by way of continuous gentle force. tooth malocclusion in patients with permanent dentition (i.e. all second molars). The ClearCorrect System positions teeth The ClearCorrect retainers are produced from single-layer rigid polyurethane film. {5}------------------------------------------------ The ClearCorrect engager templates are produced from single-layer rigid PETG film. | Technological<br>Characteristics: | A comparison of the relevant technological characteristics<br>between the subject and primary predicate devices is provided<br>in the table that follows. | |-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------| |-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------| Performance Data: Assessment of the risks associated with the subject device presented in this submission indicate that the following studies establish the substantial equivalence of the subject device to the identified predicate and reference devices: - Package integrity via simulated transport test per ISTA 2A ● - Validation of shelf life per ASTM F1980 - Biocompatibility per the ISO 10993 series standards - . Water absorption testing per ISO 62 - . Tensile performance testing per ISO 527-3 - Flexural performance testing per ISO 178 - Impact performance testing per ISO 8256 - Tear resistance testing per ISO 6383-1 - Fatigue resistance testing per ASTM D7774 - . Stress relaxation testing - Dimensional stability per internal methods - Usability testing per IEC 62366-1 - . Software development per IEC 62304 Conclusions: Based upon our assessment of the design and applicable performance data, the subject devices have been determined to be substantially equivalent to the identified predicate devices. {6}------------------------------------------------ | Feature | Subject Device<br>ClearCorrect System | Primary Predicate Device<br>ClearCorrect System<br>(K113618) | Reference Device<br>Ormco™ SparkTM Aligner<br>System<br>(K182826) | Equivalence Discussion | |-----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications<br>for Use | The ClearCorrect System is<br>indicated for the treatment of<br>tooth malocclusion in patients<br>with permanent dentition (i.e. all<br>second molars). The<br>ClearCorrect System positions<br>teeth by way of continuous<br>gentle force. | The ClearCorrect System is<br>indicated for the treatment of<br>tooth malocclusion in patients<br>with permanent dentition (i.e. all<br>second molars). The<br>ClearCorrect System positions<br>teeth by way of continuous<br>gentle force. | The Ormco™ SparkTM Aligner<br>System is indicated for the<br>alignment of teeth during<br>orthodontic treatment of<br>malocclusion in patients with<br>permanent dentition (i.e. all<br>second molars). The Ormco™<br>SparkTM Aligner System<br>positions teeth by way of<br>continuous gentle force. | Identical<br>The indication for the Subject<br>device is the same as for the<br>Primary Predicate device. | | Target<br>Patient<br>Population | Adults (> 21 y.o.)<br>Adolescents (12 – 21 y.o. having<br>permanent second molars) | Adults (> 21 y.o.)<br>Adolescents (12 – 21 y.o. having<br>permanent second molars) | Adults (> 21 y.o.)<br>Adolescents (12 – 21 y.o. having<br>permanent second molars) | Identical | | Mode of<br>Action /<br>Operating<br>Principle | The aligner is an orthodontic<br>appliance intended for intra-oral<br>use. Individual devices will be<br>used between 20 – 22 hours per<br>day for a period ranging from<br>one to three weeks<br><br>The corrective forces to align<br>teeth are primarily generated by<br>the difference between the<br>starting tooth position and the<br>planned tooth position defined<br>by the tray. Features can be<br>added to the aligner that engage<br>with composite resin tooth<br>attachments to improve aligner<br>retention and/or to apply force in<br>directions that cannot be<br>achieved by engaging with tooth<br>surfaces alone. | The aligner is an orthodontic<br>appliance intended for intra-oral<br>use. Individual devices will be<br>used between 20 – 22 hours per<br>day for a period ranging from<br>one to three weeks<br><br>The corrective forces to align<br>teeth are primarily generated by<br>the difference between the<br>starting tooth position and the<br>planned tooth position defined<br>by the tray. Features can be<br>added to the aligner that engage<br>with composite resin tooth<br>attachments to improve aligner<br>retention and/or to apply force in<br>directions that cannot be<br>achieved by engaging with tooth<br>surfaces alone. | The corrective forces to align<br>teeth are primarily generated by<br>the difference between the<br>starting tooth position and the<br>planned tooth position defined<br>by the tray. Features can be<br>added to the aligner that engage<br>with composite resin tooth<br>attachments to improve aligner<br>retention and/or to apply force in<br>directions that cannot be<br>achieved by engaging with tooth<br>surfaces alone. | Identical | | Feature | Subject Device<br>ClearCorrect System | Primary Predicate Device<br>ClearCorrect System<br>(K113618) | Reference Device<br>Ormco™ SparkTM Aligner<br>System<br>(K182826) | Equivalence Discussion | | Aligner<br>Material | Thermoplastic polyurethane-<br>polyester composite resin,<br>tradename ClearQuartz | Thermoplastic polyurethane film | Thermoplastic polyurethane-<br>polyester composite resin. | Equivalent<br>The Subject device has a<br>multilayer construction of<br>polyurethane and co-polyester<br>resins. The Reference Device<br>also has a multilayer<br>construction of polyurethane and<br>co-polyester resins. | | Retainer<br>Material | 0.030" rigid polyurethane film | 0.030" rigid polyurethane film | Not relevant | Identical<br>The Retainer of the ClearCorrect<br>System is unchanged from the<br>previously cleared device. | | Engager<br>Template<br>Material | 0.5 mm (0.02") rigid PETG film | 0.5 mm (0.02") rigid PETG film | Not relevant | Identical<br>The Engager Template of the<br>ClearCorrect System is<br>unchanged from the previously<br>cleared device. | | Sterilization | Provided in non-sterile<br>condition. Not intended to be<br>sterilized before use. | Provided in non-sterile<br>condition. Not intended to be<br>sterilized before use. | Not relevant | Identical<br>The status of the Subject devices<br>is identical to that of the Primary<br>Predicate devices. | | Singe Use/<br>Reuse | Repeated use by a single patient | Repeated use by a single patient | Repeated use by a single patient | Identical<br>The use profile of the Subject<br>devices is identical to that of the<br>Primary Predicate devices. | | Packaging | Primary: LDPE bag containing<br>one or two appliances as defined<br>by the prescribed treatment plan.<br>Secondary: 20 pt C1S SBS<br>paperboard box | Primary: LDPE bag containing<br>one or two appliances as defined<br>by the prescribed treatment plan.<br>Secondary: 20 pt C1S SBS<br>paperboard box | Not relevant | Identical<br>The packaging for the Subject<br>devices is identical to that of the<br>Primary Predicate devices. | {7}------------------------------------------------