Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary does not mention AI or ML, and the description focuses on the physical aligner system and manufacturing process.

Therapeutic

Yes.
The device is used for the treatment of tooth malocclusion, correcting misaligned teeth through continuous gentle force.

Diagnostic

No

The Eon Aligners are described as a treatment device for tooth malocclusion, not a device used to identify or diagnose a condition. Its function is to move teeth, not to perform a diagnostic assessment.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "custom clear aligner system" and "a series of doctor-approved clear plastic removable aligners," indicating a physical, hardware component. The performance studies also mention "additive manufacturing of tooth model" and "final aligners," further confirming the presence of physical components.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Eon Aligners' Function: Eon Aligners are a physical device used to mechanically move teeth. They do not perform any tests on biological samples to diagnose or monitor a condition.
Intended Use: The intended use is for the "treatment of tooth malocclusion," which is a physical correction, not a diagnostic process.
Input: The input is a 3D scan or impression of the teeth, which is a physical representation, not a biological sample for testing.

Therefore, Eon Aligners fall under the category of a medical device used for treatment, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

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.

Product codes

NXC

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.

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

3D intraoral scan

Anatomical Site

tooth malocclusion

Indicated Patient Age Range

patients with permanent dentition (i.e., all second molars).

Intended User / Care Setting

Orthodontist (prescribes, reviews and approves treatment setup, dispenses, and monitors)

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K182826

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is 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.

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
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
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.

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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.

| | Biological
endpoint | Supporting
data from
literature | Test Article | Rationale for why additional
information is not required |
|----|------------------------------------------------------------------------------------------------------------------|---------------------------------------|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | Cytotoxicity -
MEM Elution (ISO
10993-5) | na | Thermoformed
Sheet | The thermoformed sheet shows
no cytotoxicity |
| 2 | Cytotoxicity study
per ISO 10993-
5:2009 | na | Aligner material | Aligner material does not show
any cytotoxicity |
| 3 | Maximization
Test for delayed-
type
hypersensitivity
(ISO 10993-10) | na | Thermoformed
Sheet | The thermoformed sheet does
not demonstrate any
hypersensitivity |
| | Biological
endpoint | Supporting
data from
literature | Test Article | Rationale for why additional
information is not required |
| 4 | Intracutaneous
Reactivity Test
(ISO 10993-10) | na | Thermoformed
Sheet | The thermoformed sheet does
not demonstrate any
intracutaneous reactivity |
| 5 | Oral Mucosal
Irritation Test
(ISO 10993-10) | na | Thermoformed
sheet | The thermoformed sheet does
not demonstrate any oral
mucosal irritation |
| 6 | Bacterial reverse
mutation assay
(Ames test) per
ISO 10993-3:2014 | na | Aligner material | Aligner material does not
demonstrate any genotoxicity,
test article did not induce
mutations in bacterial reverse
mutation study |
| 7 | In vitro
mammalian cell
TK gene mutation
test per ISO
10993-3:2014 | na | Aligner material | Aligner material does not
demonstrate any genotoxicity,
chromosomal aberrations in an in
vitro mammalian cell TK gene
mutation study |
| 8 | Skin irritation
study in the
Japanese white
rabbit per ISO
10993-10:2010 | na | Aligner material | Aligner material does not
demonstrate any skin irritation |
| 9 | Skin sensitization
test per ISO
10993-10:2010 | na | Aligner material | Aligner material does not
demonstrate skin sensitization |
| 10 | Tests for systemic
toxicity/Subchron
ic systemic
toxicity test (oral
route) per ISO
10993-11:2017 | na | Aligner material | Aligner material does not
demonstrate any sub chronic
clinical toxicity |
| 11 | In vitro
mammalian
chromosome
aberration test | NA | Aligner material | Aligner material does not
demonstrate chromosomal
abberrations. |

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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

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
Name	Sequential Aligners	Sequential Aligners	Same
Classification
Number	872.5470	872.5470	Same
Product Code	NXC	NXC	Same
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	Ormco Spark Aligner System
are indicated for the
treatment of tooth
malocclusion in patients with
permanent dentition (i.e., all
second molars). Ormco	Same
	way of continuous gentle
force.	Spark Aligner System
positions teeth by way of
continuous gentle force.
Mechanism of
Action	Orthodontic movement
occurs by means of gentle
forces which are applied on
the teeth by the aligner
which follows the
programmed movement
approved by the dental
health professional.	Orthodontic movement
occurs by means of gentle
forces which are applied on
the teeth by the aligner
which follows the
programmed movement
approved by the dental
health professional.	Same
Manufacturer:	Eon Aligners	Ormco Spark Aligner System	Comparison
Patient
Population	Patients with all permanent
dentition	Patients with permanent
dentition	Same
Material(s)
Used	polyurethane-polyester
copolymer resin	polyurethane-polyester
copolymer resin	Same
Supplied
Sterile:	No	No	Same
Worn at Night:	Yes	Yes	Yes
Dental Health
Professional
Review	A dental health professional
takes the patient
impressions/scans and sends
them to the dental lab,
reviews the treatment set up
before the manufacturing
begins. The dental health
professional can reject or
modify the treatment set up
prior to approving it to begin
fabrication. The final,
fabricated aligners are sent
back to the
Dentist/Orthodontist who
dispenses them to the
patients in small sequential	A dental health professional
reviews the treatment set up
before the manufacturing
begins. The dental health
professional can reject or
modify the treatment set up
prior to approving it to begin
fabrication.	Same
	stages and monitors the
patient's orthodontic tooth
movement until the end of
patient 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.