Orthodontic Appliance

{0}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K181747 Device Name Orthodontic Appliance Indications for Use (Describe) The Orthodontic Appliance is indicated for the correction of tooth malocclusion in patients with permanent dentition. The Orthodontic Appliance moves the teeth by continuous gentle force. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------------------------|---------------------------------------------| | <span style="text-decoration: line-through;">×</span> Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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." {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the word "HUGE" in white letters on an orange oval background. The word is in all capital letters and is centered in the oval. The oval is oriented horizontally. The font is sans-serif and bold. # 005 510 (k) Summary This summary of 510(k) is being submitted in accordance with the requirements of 21 C.F.R. 807.92. - 1. Date Summary Prepared: April 14, 2019 ## 2. Submitter Information: | Name | Shandong Huge Dental Material Corporation | |-----------|------------------------------------------------------------------------------------------------| | Address | No. 68 Shanhai Road, Donggang District, Rizhao City,<br>Shandong Province, 276800, P. R. China | | Telephone | +86 633 2277285 | | Fax | +86 633 2277298 | | Contact | Ms. Maggie Zheng | | E-mail | zhengxy@hugedent.com | ## 3. Device Name: Trade name: Orthodontic Appliance Common name: Aligner, Sequential Classification name: Orthodontic plastic bracket # 4. Substantially Equivalent Device: | Company Name | Device Name | 510 (k) NO. | Substantially Equivalent<br>(SESE) Decision Date | |----------------------------|-------------------|-------------|--------------------------------------------------| | ClearPath Orthodontics Ltd | ClearPath Aligner | K162609 | 09/19/2016 | No reference devices were used in this submission. # 5. Description of Device: {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the word "HUGE" in white letters on an orange background. The word is in a bold, sans-serif font and is centered in the image. The orange background is in the shape of a rounded rectangle. The overall design is simple and eye-catching. The Orthodontic Appliance is a series of clear, lightweight, plastic aligners that are used to replace traditional orthodontic wires and brackets for the alignment of maloccluded or misaligned teeth. This series of aligners moves the teeth gently, and in small increments, from their original to their final treated position for improved dental alignment. The product is made of a polymer thermoplastic material (polyvinyl ester mixture) by pressing. The doctor-prescribed Orthodontic Appliance are provided non-sterile and are customized for each patient according to the 3D printed data designed by Clear Aligner Design Software. Shandong Huge Dental Material Corporation manufactures the Orthodontic Appliance by thermoforming commercially available thermoplastic material and send them to the clinician. The clinician confirms the fit of the aligners upon delivery to the patient and monitors the patient's progress throughout treatment. Depending on the patient need and the treatment plan, a series of aligners may be used. The duration of use for each pair of appliance is 2-3 weeks, wear the appliances for at least 20 hours every day and it is to be worn except during eating or cleaning of the oral cavity. The type of Orthodontic Appliance is LX-A with various thickness so that the clinician can select suitable thickness based on patients' teeth micromaxillary deformity conditions. Different thickness are identical in chemical compositions, indications for use, functions, performance characteristics, operation principle and other aspects. ## 6. Intended for Use / including the indications for use: The Orthodontic Appliance is indicated for the correction of tooth malocclusion in patients with permanent dentition. The Orthodontic Appliance moves the teeth by continuous gentle force. #### 7. Mechanism of Action: The mechanism of action is similar to the predicate device and supports a determination of substantial equivalence. Orthodontic tooth movement occurs through continuous gentle force applied to the teeth by the appliance based on a healthcare practitioner's prescription. {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the word "HUGE" in white letters on an orange oval background. The word is in all capital letters and is centered in the oval. The oval is oriented horizontally. The font is sans-serif and bold. ## 8. Technological Characteristics: Treatment of tooth malocclusions via a series of plastic appliances that incrementally moves the teeth to a desired final position is the technological principle for both the subject device and the predicate device. A comparison of technological characteristics between the subject device and the predicate device has been performed. The results of this comparison demonstrate that the indications for use, design, technological characteristics, mechanism of action, performance, materials and biocompatibility are substantially equivalent. | Table 3: Device Comparison Table | | | | | |----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--| | Comparison Items | Subject Device | Predicate Device | | | | Device Name | Orthodontic Appliance | ClearPath Aligner | | | | 510 (k) Number | To be determined | K162609 | | | | Regulation Number | 21 C.F.R. 872.5470 | 21 C.F.R. 872.5470 | | | | Product Code | NXC | NXC | | | | Classifications | Class II | Class II | | | | Indications for use | The Orthodontic Appliance is indicated<br>for the correction of tooth malocclusion<br>in patients with permanent dentition.<br>The Orthodontic Appliance moves the<br>teeth by continuous gentle force. | The ClearPath Aligner is a series of<br>clear, lightweight, plastic appliances<br>indicated for the correction of dental<br>malocclusion in patients with<br>permanent dentition (i.e. all second<br>molars). The ClearPath Aligner is<br>intended to position teeth by way of<br>continuous gentle force. | | | | Material | Thermoplastic material | Thermoplastic material | | | | Mechanism of Action | Continuous gentle force applied to teeth<br>to achieve movement. | Continuous gentle force applied to teeth<br>to achieve movement. | | | | Manufacturing method | Thermoforming. | Thermoforming. | | | | Conditions of Use | The duration of use for each pair of<br>appliance is 2-3 weeks, wear the<br>appliances for at least 20 hours every<br>day and it is to be worn except during<br>eating or cleaning of the oral cavity. | The duration of use for each pair of<br>appliance is 2-3 weeks, wear the<br>appliances for at least 20 hours every<br>day and it is to be worn except during<br>eating or cleaning of the oral cavity. | | | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the word "HUGE" in white letters on an orange oval background. The word is written in a bold, sans-serif font. The oval is oriented horizontally. The overall design is simple and eye-catching. Shandong Huge Dental Material Corporation www.hugedental.com T / +86 633 2277285 F / +86 633 2277298 No.68 Shanhai Road, Donggang District, Rizhao Shandong Province, 276800, P.R.China | Table 3: Device Comparison Table | | | |------------------------------------------------------------------|------------------------------------------------------------------|------------------------------------------------------------------| | Comparison Items | Subject Device | Predicate Device | | Device Name | Orthodontic Appliance | ClearPath Aligner | | 510 (k) Number | To be determined | K162609 | | The treatment plan varies by individual<br>patient prescription. | The treatment plan varies by individual<br>patient prescription. | The treatment plan varies by individual<br>patient prescription. | | Biocompatibility | Biocompatible | Biocompatible | | Sterility | Non-sterile | Non-sterile | | Anatomical Site | Used by dentist or orthodontist on<br>teeth for dental patients. | Used by dentist or orthodontist on teeth<br>for dental patients. | #### 9. Summary of Non-Clinical Performance Testing: There is no international/industrial standards regarding the performance of this product. The performance testing for the subject device was performed and showed that the subject device meets all internal final inspection standard, while the physical and mechanical properties as well as the biocompability of the thermoplastic materials used to fabricate the aligners have previously been demonstrated by the manufacturer of the base materials. The test items include appearance and surface characteristics, dimensions, pH value, elasticity variable, volume weight, water sorption, solubility. Meanwhile, the comparative testing was conducted between the proposed and the predicate device to determine substantial equivalence. #### 10. Summary of Biocompatibility: The thermoplastic material used for fabrication of the aligners is commonly used in many dental appliances, which has a long history of safe and biocompatible use for this purpose. And there is sufficient information from the predicate device to demonstrate that this product provide reasonable assurance of safety and effectiveness. The formulation of the subject device does not contain any new or non-conventional chemicals compared to the legally marketed predicate device. Biocompatibility tests were performed to satisfied the ISO 10993 standards. The test results of {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the word "HUGE" in white letters on an orange background. The word is in all capital letters and is centered in the image. The background is a rounded shape, similar to an oval. The font is sans-serif and appears to be bold. the tests met the requirements of the study protocols, the tests including Cytotoxicity (ISO 10993-5), Skin Sensitization (ISO 10993-10), Intracutaneous Reactivity (ISO 10993-10), Subchronic systemic toxicity (ISO 10993-11) and Genotoxicity (ISO 10993-3). #### 11. Summary of Clinical Performance Data: The performance of Orthodontic Appliance in the clinical environment has been well established since the first such devices were cleared by the FDA in 1998 under product code NXC. Therefore, there was no clinical testing required to support Orthodontic Appliance, as the indications for use is equivalent to the predicate device. The substantial equivalence of the subject device to the ClearPath Aligner is supported by the non-clinical testing that was performed, along with other supporting documentation, and presented in this submission. #### 12. Software Verification and Validation Testing Software verification and validation testing were conducted on the software that facilitates ordering and processing of the Orthodontic Appliance to support that the device is as safe and effective as the predicates. Documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". The software for this device was considered as a "moderate" level of concern. #### 13. Summary of Substantial Equivalence The subject device, Orthodontic Appliance, has substantially equivalent Indications for Use as the identified predicate device. While the verbiage of the Indications of Use of the subject device is minor different than the declared predicate device; however, these minor differences are not of significance and do not alter the intended therapeutic use of the device as compared to the predicate device. The conclusions drawn from the data included in this submission, demonstrates that the subject {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the word "HUGE" in white letters on an orange background. The background is in the shape of a rounded rectangle. The letters are bold and sans-serif. The image is simple and eye-catching. device, Orthodontic Appliance, is substantially equivalent to the predicate device in indications for use, design, technological characteristics, mechanism of action, performance, materials and biocompatibility. ## 14. Photo of the device Image /page/6/Picture/5 description: The image shows a clear plastic dental aligner on a black reflective surface. The aligner is designed to fit over the teeth and is used to straighten them over time. The aligner is transparent, which makes it less noticeable than traditional braces. The reflection of the aligner on the black surface creates a mirror image, enhancing the visual appeal of the photograph. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. April 18, 2019 Shandong Huge Dental Material Corporation Maggie Zheng Regulatory Affairs Manager No. 68 Shanhai Road, Donggang District Rizhao City, Shandong Province 276800 PEOPLE'S REPUBLIC OF CHINA Re: K181747 Trade/Device Name: Orthodontic Appliance Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: March 6, 2019 Received: March 11, 2019 #### Dear Maggie Zheng: 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. {8}------------------------------------------------ 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure