(13 days)
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.
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.
The Eon Aligner device is an orthodontic plastic bracket used for the treatment of tooth malocclusion in patients with permanent dentition. The provided text outlines the device's characteristics and the studies performed to demonstrate its substantial equivalence to a predicate device (Ormco Spark Aligner System, K182826).
1. Table of Acceptance Criteria and Reported Device Performance
The submission focuses on establishing substantial equivalence to a predicate device, rather than defining specific performance metrics typically found in AI/ML performance studies (e.g., sensitivity, specificity, AUC). Instead, the acceptance criteria are based on demonstrating equivalence in materials, manufacturing processes, intended use, operating principles, and biocompatibility.
| Acceptance Criteria Category | Reported Device Performance (Eon Aligner) |
|---|---|
| Intended 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. This is identical to the predicate device. |
| Mechanism of Action | Orthodontic movement occurs by means of gentle forces applied on the teeth by the aligner, following a programmed movement approved by the dental health professional. This is identical to the predicate device. |
| Patient Population | Patients with all permanent dentition. This is identical to the predicate device. |
| Materials Used | Polyurethane-polyester copolymer resin. This is identical to the predicate device. |
| Sterility | Not supplied sterile. This is identical to the predicate device. |
| Wear at Night | Yes. This is identical to the predicate device. |
| Dental Health Professional Review | A dental health professional takes patient impressions/scans, sends them to the dental lab, reviews the treatment setup, and can reject or modify it before approval. Final aligners are dispensed by the dentist/orthodontist who monitors the patient's orthodontic movement. This workflow is described as similar to the predicate. |
| Biocompatibility | Passed all 11 listed biocompatibility tests (Cytotoxicity, Maximization Test for delayed-type hypersensitivity, Intracutaneous Reactivity Test, Oral Mucosal Irritation Test, Bacterial reverse mutation assay, In vitro mammalian cell TK gene mutation test, Skin irritation study, Skin sensitization test, Tests for systemic toxicity/Subchronic systemic toxicity test, In vitro mammalian chromosome aberration test). The device materials are identical to the predicate, and these tests confirm no adverse biological effects. |
| Manufacturing Workflow Validation | A manufacturing fit validation study in two parts: 1) established steps for aligners from manual impressions and digital scans. 2) Recreated 3D printed models and aligners from eight patients with successful malocclusion treatment. Results demonstrated minimal differences between digital inputs and final aligners, validating the workflow. |
2. Sample Size Used for the Test Set and Data Provenance
The manufacturing fit validation study used a sample size of eight (8) patients who had successfully undergone malocclusion treatment. The provenance of this data (e.g., country of origin, retrospective or prospective) is not explicitly stated in the provided text. It is assumed to be retrospective as it involved re-creating models from "successfully undergone malocclusion treatment."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The text does not explicitly state the number of experts or their qualifications for establishing the ground truth for the manufacturing fit validation study. The study involved recreating 3D printed models and aligners based on "successful treatment," implying that the "ground truth" was the outcome of successful treatment as prescribed and achieved by a dentist/orthodontist. The process involves a "prescribing physician" reviewing and approving the treatment setup, suggesting ongoing expert involvement, but not a specific ground truth adjudication panel for the manufacturing validation.
4. Adjudication Method for the Test Set
The text does not describe an adjudication method (e.g., 2+1, 3+1) in the context of an expert review panel for the manufacturing fit validation study. The standard for "ground truth" in this context appears to be the successful outcome of malocclusion treatment for the eight patients. The validation aimed to show that the manufacturing process could accurately reproduce the digital plan, with differences being "minimal."
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not performed, nor is it applicable to this type of device submission. The Eon Aligner is a physical medical device (orthodontic plastic bracket), not an AI-assisted diagnostic or therapeutic tool for which human-reader performance would be evaluated. The submission focuses on demonstrating the physical and functional equivalence of the device to an existing predicate.
6. Standalone (Algorithm Only) Performance Study
A standalone performance study for an algorithm was not performed, as the Eon Aligner is a physical medical device. While the device relies on "dental software intended for tooth alignment" for its design, the submission focuses on the manufactured product and its biological interaction, not the performance of the software itself as a standalone diagnostic tool. The manufacturing workflow validation included aspects of the "design software" and "3D-Printing," validating the process of creating the aligners, not the interpretative accuracy of the algorithm.
7. Type of Ground Truth Used
For the manufacturing fit validation study: The ground truth was based on the successful outcome of malocclusion treatment in eight (retrospective) patients, where the 3D printed models and aligners were recreated to demonstrate that the manufacturing process could achieve the intended therapeutic outcome with minimal deviation from the digital plan.
For biocompatibility: The ground truth was established by standardized laboratory tests per ISO 10993 series and confirmed against the identical materials of the predicate device.
8. Sample Size for the Training Set
The text does not mention a training set in the context of an AI/ML algorithm. The "training" for this device would relate to the manufacturing validation and biocompatibility, not an algorithmic model.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of an algorithm training set, this question is not applicable. The ground truth for the manufacturing validation was indirectly established by the successful treatment outcomes of previously treated patients. The "prescribing physician reviews and approves the treatment setup before the plastic trays are produced," implying that the clinician's approval of the treatment plan serves as the internal 'ground truth' for the design stage.
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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
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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
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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)
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K202685 510k Summary
| 510k Owner | Eon Dental Jordan LLC |
|---|---|
| 510k Owner Address: | 385 King Abdullah II Street.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 |
| 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 SystemClearance 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.
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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.
| Biologicalendpoint | Supportingdata fromliterature | Test Article | Rationale for why additionalinformation is not required | |
|---|---|---|---|---|
| 1 | Cytotoxicity -MEM Elution (ISO10993-5) | na | ThermoformedSheet | The thermoformed sheet showsno cytotoxicity |
| 2 | Cytotoxicity studyper ISO 10993-5:2009 | na | Aligner material | Aligner material does not showany cytotoxicity |
| 3 | MaximizationTest for delayed-typehypersensitivity(ISO 10993-10) | na | ThermoformedSheet | The thermoformed sheet doesnot demonstrate anyhypersensitivity |
| Biologicalendpoint | Supportingdata fromliterature | Test Article | Rationale for why additionalinformation is not required | |
| 4 | IntracutaneousReactivity Test(ISO 10993-10) | na | ThermoformedSheet | The thermoformed sheet doesnot demonstrate anyintracutaneous reactivity |
| 5 | Oral MucosalIrritation Test(ISO 10993-10) | na | Thermoformedsheet | The thermoformed sheet doesnot demonstrate any oralmucosal irritation |
| 6 | Bacterial reversemutation assay(Ames test) perISO 10993-3:2014 | na | Aligner material | Aligner material does notdemonstrate any genotoxicity,test article did not inducemutations in bacterial reversemutation study |
| 7 | In vitromammalian cellTK gene mutationtest per ISO10993-3:2014 | na | Aligner material | Aligner material does notdemonstrate any genotoxicity,chromosomal aberrations in an invitro mammalian cell TK genemutation study |
| 8 | Skin irritationstudy in theJapanese whiterabbit per ISO10993-10:2010 | na | Aligner material | Aligner material does notdemonstrate any skin irritation |
| 9 | Skin sensitizationtest per ISO10993-10:2010 | na | Aligner material | Aligner material does notdemonstrate skin sensitization |
| 10 | Tests for systemictoxicity/Subchronic systemictoxicity test (oralroute) per ISO10993-11:2017 | na | Aligner material | Aligner material does notdemonstrate any sub chronicclinical toxicity |
| 11 | In vitromammalianchromosomeaberration test | NA | Aligner material | Aligner material does notdemonstrate chromosomalabberrations. |
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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
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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 | |
| CommonName | Sequential Aligners | Sequential Aligners | Same |
| ClassificationNumber | 872.5470 | 872.5470 | Same |
| Product Code | NXC | NXC | Same |
| Intended Use | Eon Aligners are indicatedfor the treatment of toothmalocclusion in patients withpermanent dentition (i.e., allsecond molars). Eon AlignerSystem positions teeth by | Ormco Spark Aligner Systemare indicated for thetreatment of toothmalocclusion in patients withpermanent dentition (i.e., allsecond molars). Ormco | Same |
| way of continuous gentleforce. | Spark Aligner Systempositions teeth by way ofcontinuous gentle force. | ||
| Mechanism ofAction | Orthodontic movementoccurs by means of gentleforces which are applied onthe teeth by the alignerwhich follows theprogrammed movementapproved by the dentalhealth professional. | Orthodontic movementoccurs by means of gentleforces which are applied onthe teeth by the alignerwhich follows theprogrammed movementapproved by the dentalhealth professional. | Same |
| Manufacturer: | Eon Aligners | Ormco Spark Aligner System | Comparison |
| PatientPopulation | Patients with all permanentdentition | Patients with permanentdentition | Same |
| Material(s)Used | polyurethane-polyestercopolymer resin | polyurethane-polyestercopolymer resin | Same |
| SuppliedSterile: | No | No | Same |
| Worn at Night: | Yes | Yes | Yes |
| Dental HealthProfessionalReview | A dental health professionaltakes the patientimpressions/scans and sendsthem to the dental lab,reviews the treatment set upbefore the manufacturingbegins. The dental healthprofessional can reject ormodify the treatment set upprior to approving it to beginfabrication. The final,fabricated aligners are sentback to theDentist/Orthodontist whodispenses them to thepatients in small sequential | A dental health professionalreviews the treatment set upbefore the manufacturingbegins. The dental healthprofessional can reject ormodify the treatment set upprior to approving it to beginfabrication. | Same |
| stages and monitors thepatient's orthodontic toothmovement until the end ofpatient aligner treatment'. |
Substantial Equivalence Table:
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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.
§ 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.