Eon Aligner

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September 28, 2020 Eon Dental Jordan LLC % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114 Re: K202685 Trade/Device Name: Eon Aligner Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic plastic bracket Regulatory Class: Class II Product Code: NXC Dated: September 14, 2020 Received: September 15, 2020 Dear Prithul Bom: 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 {1}------------------------------------------------ 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 medical devices and radiation-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, for Srinivas "Nandu" Nandkumar, Ph.D., Director DHT1B: Division of Dental 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) K202685 Device Name Eon Dental Aligner Indications for Use (Describe) Eon Aligners are indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e., all second molars). Eon Aligner System positions 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." {3}------------------------------------------------ # K202685 510k Summary | 510k Owner | Eon Dental Jordan LLC | |---------------------------|-------------------------------------------------------------------| | 510k Owner Address: | 385 King Abdullah II Street.<br>Amman 11810 Jordan | | Contact: | Fadi Samawi / Director of Manufacturing | | Phone: | +(962)780606066 | | Email: | f.samawi@eonaligner.com | | Submission Correspondent: | Shree Koushik Ph.D. RAC | | | BDRA Consulting LLC | | | 1 Clearwater Court, Damascus, MD 20872 | | Phone | 301-922-7231 | | Email | bdraconsulting@gmail.com | | Date Prepared: | September 11, 2020 | | Device Trade Name: | Eon Aligner | | Classification Name | Orthodontic Plastic Bracket | | Common Name: | Sequential Aligner | | Classification Number | 21 CFR 872.5470 | | Product Code | NXC | | Classification | 2 | | Predicate Device | K182826, Ormco Spark Aligner System<br>Clearance Date: 10/11/2018 | Intended Use / Indications for Use: Eon Aligners are indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e., all second molars). Eon Aligner System positions teeth by way of continuous gentle force Device Description: The Eon Aligners is a custom clear aligner system. They are a series of doctor-approved clear plastic removable aligners that are used as alternative traditional orthodontic wires and brackets for the alignment of maloccluded or misaligned teeth. This series of aligner moves the teeth gently, and in small increments, from their original misalignment to their final treated position for improved dental alignment. {4}------------------------------------------------ An orthodontist prescribes Eon Aligners based on an assessment of the patient's teeth using a 3D intraoral scan of the patient's teeth or a physical impression. The 3D intraoral scan or physical impression are then sent to Eon Dental. The impressions are scanned using standard validated software. Using dental software intended for tooth alignment, Eon Dental designs a series of plastic trays intended to progressively realign the patient's teeth which conforms with the orthodontist's prescription. The prescribing physician reviews and approves the treatment setup before the plastic trays are produced. The treatment set up which includes a video animation of how the teeth will move during the aligner treatment and the final alignment results. Once approved, Eon Dental produces a series of dental models that correspond to the treatment stages using additive manufacturing techniques. The 3D printed models are used to manufacture the aligners using standard technique. The aligner trays for each treatment stage is thermoformed using clear thermoplastic polyurethane-polyester composite resin material. The scanning design software, 3D-Printing and aligner manufacturing was validated, and the study concluded that Eon can manufacture the aligners as intended. #### Operating Principle: Each progressive aligner is intended to be worn for 2 weeks, where gentle force is applied (by the aligner) to achieve progressive realignment of the teeth till the teeth are aligned as per treatment plan. Similar to predicates and traditional braces the treatment plan proceeds over time under clinician supervision. #### Biocompatibility testing The biocompatibility evaluation and the determination that Eon Aligners and the predicate devices are made from identical the material components, using similar manufacturing processes, and are used in the identical manner, including the intended anatomical location and the frequency and duration of exposure, Eon concludes that Eon Aligners are biocompatible for their intended use. The following biocompatibility assessments were performed by thermoplastic polymers manufacturer were included in the submission. | | Biological<br>endpoint | Supporting<br>data from<br>literature | Test Article | Rationale for why additional<br>information is not required | |----|------------------------------------------------------------------------------------------------------------------|---------------------------------------|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------| | 1 | Cytotoxicity -<br>MEM Elution (ISO<br>10993-5) | na | Thermoformed<br>Sheet | The thermoformed sheet shows<br>no cytotoxicity | | 2 | Cytotoxicity study<br>per ISO 10993-<br>5:2009 | na | Aligner material | Aligner material does not show<br>any cytotoxicity | | 3 | Maximization<br>Test for delayed-<br>type<br>hypersensitivity<br>(ISO 10993-10) | na | Thermoformed<br>Sheet | The thermoformed sheet does<br>not demonstrate any<br>hypersensitivity | | | Biological<br>endpoint | Supporting<br>data from<br>literature | Test Article | Rationale for why additional<br>information is not required | | 4 | Intracutaneous<br>Reactivity Test<br>(ISO 10993-10) | na | Thermoformed<br>Sheet | The thermoformed sheet does<br>not demonstrate any<br>intracutaneous reactivity | | 5 | Oral Mucosal<br>Irritation Test<br>(ISO 10993-10) | na | Thermoformed<br>sheet | The thermoformed sheet does<br>not demonstrate any oral<br>mucosal irritation | | 6 | Bacterial reverse<br>mutation assay<br>(Ames test) per<br>ISO 10993-3:2014 | na | Aligner material | Aligner material does not<br>demonstrate any genotoxicity,<br>test article did not induce<br>mutations in bacterial reverse<br>mutation study | | 7 | In vitro<br>mammalian cell<br>TK gene mutation<br>test per ISO<br>10993-3:2014 | na | Aligner material | Aligner material does not<br>demonstrate any genotoxicity,<br>chromosomal aberrations in an in<br>vitro mammalian cell TK gene<br>mutation study | | 8 | Skin irritation<br>study in the<br>Japanese white<br>rabbit per ISO<br>10993-10:2010 | na | Aligner material | Aligner material does not<br>demonstrate any skin irritation | | 9 | Skin sensitization<br>test per ISO<br>10993-10:2010 | na | Aligner material | Aligner material does not<br>demonstrate skin sensitization | | 10 | Tests for systemic<br>toxicity/Subchron<br>ic systemic<br>toxicity test (oral<br>route) per ISO<br>10993-11:2017 | na | Aligner material | Aligner material does not<br>demonstrate any sub chronic<br>clinical toxicity | | 11 | In vitro<br>mammalian<br>chromosome<br>aberration test | NA | Aligner material | Aligner material does not<br>demonstrate chromosomal<br>abberrations. | {5}------------------------------------------------ Status: All tests passed. Since all tests passed, Eon ## Animal or Human testing Eon Aligners are composed of identical material components as the predicate devices, using similar manufacturing processes. They have the same intended use, including the same {6}------------------------------------------------ intended anatomical location and frequency and duration of use. Therefore, animal and human testing was not determined to be necessary. ### Non-Clinical Testing Nonclinical testing performed evaluating multiple typical malocclusions that can be corrected by Eon Aligner. The manufacturing workflow, treatment design, additive manufacturing of tooth model and design software was performed. Eon conducted a manufacturing fit validation study in two parts. The first part they established the for the steps involved in the process for aligners made from manual impressions and digital scans. In the second part Eon recreated 3D printed models and aligners from eight patients that had successfully undergone malocclusion treatment. The results demonstrated that the Eon Aligner can be manufactured with minimal differences between the digital inputs and final aligners demonstrating the manufacturing workflow has been validated and demonstrates that Eon can manufacture products to support intended use of the device. Substantial Equivalence: Eon Aligners have an identical intended use compared to the Predicate, identical materials, has identical operating principles, and uses similar manufacturing processes, Eon Dental concludes that their aligners are substantially equivalent to the predicate device. | Manufacturer: | Eon Aligners | Ormco Spark Aligner System | Comparison | |-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | 510k Number | NA | K182826 | | | Common<br>Name | Sequential Aligners | Sequential Aligners | Same | | Classification<br>Number | 872.5470 | 872.5470 | Same | | Product Code | NXC | NXC | Same | | Intended Use | Eon Aligners are indicated<br>for the treatment of tooth<br>malocclusion in patients with<br>permanent dentition (i.e., all<br>second molars). Eon Aligner<br>System positions teeth by | Ormco Spark Aligner System<br>are indicated for the<br>treatment of tooth<br>malocclusion in patients with<br>permanent dentition (i.e., all<br>second molars). Ormco | Same | | | way of continuous gentle<br>force. | Spark Aligner System<br>positions teeth by way of<br>continuous gentle force. | | | Mechanism of<br>Action | Orthodontic movement<br>occurs by means of gentle<br>forces which are applied on<br>the teeth by the aligner<br>which follows the<br>programmed movement<br>approved by the dental<br>health professional. | Orthodontic movement<br>occurs by means of gentle<br>forces which are applied on<br>the teeth by the aligner<br>which follows the<br>programmed movement<br>approved by the dental<br>health professional. | Same | | Manufacturer: | Eon Aligners | Ormco Spark Aligner System | Comparison | | Patient<br>Population | Patients with all permanent<br>dentition | Patients with permanent<br>dentition | Same | | Material(s)<br>Used | polyurethane-polyester<br>copolymer resin | polyurethane-polyester<br>copolymer resin | Same | | Supplied<br>Sterile: | No | No | Same | | Worn at Night: | Yes | Yes | Yes | | Dental Health<br>Professional<br>Review | A dental health professional<br>takes the patient<br>impressions/scans and sends<br>them to the dental lab,<br>reviews the treatment set up<br>before the manufacturing<br>begins. The dental health<br>professional can reject or<br>modify the treatment set up<br>prior to approving it to begin<br>fabrication. The final,<br>fabricated aligners are sent<br>back to the<br>Dentist/Orthodontist who<br>dispenses them to the<br>patients in small sequential | A dental health professional<br>reviews the treatment set up<br>before the manufacturing<br>begins. The dental health<br>professional can reject or<br>modify the treatment set up<br>prior to approving it to begin<br>fabrication. | Same | | | stages and monitors the<br>patient's orthodontic tooth<br>movement until the end of<br>patient aligner treatment'. | | | Substantial Equivalence Table: {7}------------------------------------------------ {8}------------------------------------------------ Conclusion Since Eon Aligners have an identical intended use compared to the Predicate, identical materials, has identical operating principles, and uses similar manufacturing processes, Eon Dental concludes that their aligners are substantially equivalent to the predicate device.