Who is the manufacturer of iOrtho?

Shanghai EA Medical Instruments Co., Ltd. filed the 510(k) submission for iOrtho (K223518).

What is the FDA product code for iOrtho?

PNN. It is classified under 21 CFR 872.5470 as a Class 2 device in the Dental panel.

What is the regulatory pathway for iOrtho?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like iOrtho?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

iOrtho

Q: What are the predicate devices for iOrtho?

3Shape A/S Ortho System (K171634).

K223518 · Shanghai EA Medical Instruments Co., Ltd. · PNN · Jun 13, 2023 · Dental

Device Facts

Record ID	K223518
Device Name	iOrtho
Applicant	Shanghai EA Medical Instruments Co., Ltd.
Product Code	PNN · Dental
Decision Date	Jun 13, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.5470
Device Class	Class 2
Attributes	Software as a Medical Device

Indications for Use

iOrtho is intended for use as a medical front-end device providing tools for management of orthodontic cases, systematic inspection, detailed analysis, treatment simulation and virtual applians (Export of Models, Indirect Bonding Transfer Media, Sequential aligners) based on 3D models of the patient's dentition before the start of an orthodontic treatment. It can also be applied during the treatment to inspect and analyze the progress of the treatment. It can be used at the end of the treatment to evaluate if the outcome is consistent with the planned/desired treatment objectives. The use of iOrtho requires the user to have the necessary training and domain knowledge in the practice of orthodonties, as well as to have received a dedicated training in the use of the software.

Device Story

iOrtho is a standalone orthodontic software platform for dental professionals. It ingests 3D digital dental scans (STL files) to facilitate case management, diagnosis, and treatment planning. The software provides tools for auto-segmentation of gums/bone (with manual adjustment), measurement point selection, and 3D treatment simulation. It enables the design of virtual appliances, including sequential aligners and indirect bonding transfer media. The system outputs 3D models for fabrication via 3D printing. Used in clinical settings by orthodontists to monitor treatment progress and verify outcomes against planned objectives. The software aids clinical decision-making by allowing practitioners to visualize tooth movement and refine treatment plans. It benefits patients by enabling customized, precise orthodontic appliance design and progress tracking.

Clinical Evidence

No clinical data. Bench testing only. The device underwent integration, verification, and validation testing in accordance with FDA software guidance and IEC 62304 standards to confirm performance per intended use.

Technological Characteristics

Standalone software; compatible with Windows 7/Mac OS 10.12+; requires WebGL-capable video card, 2GB RAM, and internet access. Features include 3D model import (STL), auto-segmentation with manual adjustment, automated measurement point selection, and virtual appliance design. Operates via web browser (Chrome, Firefox, Safari, Edge).

Indications for Use

Indicated for orthodontic patients requiring management, inspection, analysis, treatment simulation, and virtual appliance design based on 3D dentition models. Applicable before, during, and at the end of orthodontic treatment to evaluate progress and outcomes. Requires trained orthodontic professionals.

Regulatory Classification

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.

Predicate Devices

3Shape A/S Ortho System (K171634)

Reference Devices

Wuxi EA Medical Instruments Technologies Limited Clear Aligner (K203688)
Dentsply Sirona CEREC Ortho Software (K171122)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. June 13, 2023 Shanghai EA Medical Instruments Co., Ltd. % Breanne Butler Regulatory Affairs Consultant Prime Path Medtech 1321 Upland Dr. Suite 6792 Houston, Texas 77043 Re: K223518 Trade/Device Name: iOrtho Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: PNN Dated: May 19, 2023 Received: May 19, 2023 Dear Breanne Butler: 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. {1}------------------------------------------------ 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/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 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 -S 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 Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K223518 Device Name iOrtho #### Indications for Use (Describe) iOrtho is intended for use as a medical front-end device providing tools for management of orthodontic cases, systematic inspection, detailed analysis, treatment simulation and virtual applians (Export of Models, Indirect Bonding Transfer Media, Sequential aligners) based on 3D models of the patient's dentition before the start of an orthodontic treatment. It can also be applied during the treatment to inspect and analyze the progress of the treatment. It can be used at the end of the treatment to evaluate if the outcome is consistent with the planned/desired treatment objectives. The use of iOrtho requires the user to have the necessary training and domain knowledge in the practice of orthodonties, as well as to have received a dedicated training in the use of the software. | 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}------------------------------------------------ ## 510(k) SUMMARY - K223518 A summary of 510(k) substantial equivalence information for this traditional 510(k) in accordance with the requirements of 21 CFR 807.92. | Submitter: | Shanghai EA Medical Instruments Co., Ltd. No.1619 Huishan Avenue, Huishan Economic Development Zone Wuxi, Jiangsu Province China | |-----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------| | Company Contact Person: Phone: Email: | Jessica Luo, Regulatory Affairs, Angel Align +86.0510.83591717(181) luoyuqing@angelalign.com | | Submission Correspondent: Address: Phone: Email: | Breanne Butler, Regulatory Affairs Consultant 1321 Upland Dr. Suite 6792 Houston, TX 77043 860-810-5594 bbutler@primepathmedtech.com | | Date Prepared: | June 12, 2023 | | Trade Name Name: | iOrtho | | Common Name: | Orthodontic plastic bracket (Software) | | Classification Name: | Orthodontic plastic bracket (Software) | | Product Code: | PNN | | Device Classification: | Class II, 21 CFR 872.5470 | | Predicate Device: | 3Shape A/S Ortho System (K171634) | | Reference Device: | Wuxi EA Medical Instruments Technologies Limited Clear Aligner (K203688) | | Reference Device: | Dentsply Sirona CEREC Ortho Software (K171122) | ## Device Description: iOrtho (hereafter referred to as "Proposed Device") includes modifications to the currently marketed software included in K203688, cleared October 8, 2021 (hereafter referred to as "Reference Device"). The Proposed Device is an orthodontic appliance design and treatment simulation software is for use by dental professionals to aid in diagnosis and design solutions for patients. Digital scans (3D) of a patient's dentition can be loaded into the software and the dental professional can then create treatment plans for each individual patient and their needs. The system can be used to fabricate 3D dental models {4}------------------------------------------------ using standard stereolithographic (STL) files for use in 3D printers. These models can then be used as a template for thermoforming aligners or retainers by Angel Align technicians. ## Indications for Use: iOrtho is intended for use as a medical front-end device providing tools for management of orthodontic cases, systematic inspection, detailed analysis, treatment simulation and virtual appliance design options (Export of Models, Indirect Bonding Transfer Media, Sequential aligners) based on 3D models of the patient's dentition before the start of an orthodontic treatment. It can also be applied during the treatment to inspect and analyze the progress of the treatment. It can be used at the end of the treatment to evaluate if the outcome is consistent with the planned/desired treatment objectives. The use of iOrtho requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well as to have received a dedicated training in the use of the software. Comparison to Predicate Devices: The Proposed Device is functionally equivalent to the following device: 3Shape A/S Ortho System (K171634, cleared Jan 17, 2018) (hereafter referred to as "Predicate Device"), and possesses minor differences to the previously cleared Reference Device to allow treating physicians include mandible repositioning and traction accessories during treatment planning and simulation. The following table demonstrates the functional specifications of the Proposed Device are substantially equivalent to the Predicate Device, minorly different to the Reference Device, and raises no new questions regarding safety and effectiveness of the device. | | Proposed Device: | Predicate Device: | Reference | Reference | | |--------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------| | Specification | iOrtho | 3Shape A/S Ortho System (K171634) | Device: Wuxi EA Medical Instruments Technologies Limited. Clear Aligner (K203688) | Device: Dentsply Sirona CEREC Ortho Software (K171122) | Comparison Result | | Regulation Number | 21 CFR 872.5470 | 21 CFR 872.5470 | 21 CFR 872.5470 | 21 CFR 872.5470 | Same | | Classification Name | Orthodontic Plastic Bracket (Software) | Orthodontic Plastic Bracket (Software) | Orthodontic Plastic Bracket | Orthodontic Plastic Bracket (Software) | Same as Predicate | | Product Code | PNN | PNN | NXC | PNN | Same | | Classification | Class II | Class II | Class II | Class II | Same | | Indication for Use | iOrtho | The 3Shape Ortho System™ is intended for use as a medical front-end device providing tools for management of orthodontic | Clear Aligners are indicated for the alignment of teeth during orthodontic treatment of malocclusion in patients with | CEREC Ortho Software is intended for use with image data acquired from handheld intra oral 3D cameras and | Similar to predicate | | | is intended for use as a medical front- end device | is intended for use as a medical front-end device | alignment of | intended for | | | | providing tools for management of orthodontic cases. | providing tools for management of orthodontic | teeth during | use with image | | | | orthodontic cases. | orthodontic | in patients with | cameras and | | | Specification | Proposed Device: iOrtho | Predicate Device: 3Shape A/S Ortho System (K171634) | Reference Device: Wuxi EA Medical Instruments Technologies Limited. Clear Aligner (K203688) | Reference Device: Dentsply Sirona CEREC Ortho Software (K171122) | Comparison Result | | | systematic inspection, detailed analysis, treatment simulation and virtual appliance design options (Export of Models, Indirect Bonding Transfer Media, Sequential aligners) based on 3D models of the patient's dentition before the start of an orthodontic treatment. It can also be applied during the treatment to inspect and analyze the progress of the treatment. It can be used at the end of the treatment to evaluate if the outcome is consistent with the planned/desired treatment objectives. | models, systematic inspection, detailed analysis, treatment simulation and virtual appliance design options (Custom Metal Bands, Export of Models, Indirect Bonding Transfer Media) based on 3D models of the patient's dentition before the start of an orthodontic treatment. It can also be applied during the treatment to inspect and analyze the progress of the treatment. It can be used at the end of the treatment to evaluate if the outcome is consistent with the planned/desired treatment objectives. | permanent dentition (i.e. all second molars). | desktop laboratory scanners to create 3D virtual models to be used for data acquisition and modeling analysis for orthodontic patients and conditions. The CEREC Ortho Software 3D model data can be exported to orthodontic design software to aid in the design of orthodontic appliances. | | | | The use of iOrtho requires the user to have the necessary training and domain knowledge in the practice of | The use of the Ortho System™ requires the user to have the necessary training and domain knowledge in the | | | | | | | | | | | | Specification | Proposed Device: iOrtho | Predicate Device: 3Shape A/S Ortho System (K171634) | Reference Device: Wuxi EA Medical Instruments Technologies Limited. Clear Aligner (K203688) | Reference Device: Dentsply Sirona CEREC Ortho Software (K171122) | Comparison Result | | | orthodontics, as well as to have received a dedicated training in the use of the software. | practice of orthodontics, as well as to have received a dedicated training in the use of the software. | | | | | Technological Features | Stand Alone Software Imports Digital Dental Data Useful for as an aid in Diagnosis, and treatment planning Virtual Planning of tooth movement Patient follow-up monitoring and management Cephalometry | Stand Alone Software Imports Digital Patient Scans Can be used to design Dental Casts Useful for Diagnosis, treatment planning, and CAD design Virtual Planning of tooth movement | Produce 3D-model file of the PVS impression or digital scan. Identifies the individual teeth that will require treatment (i.e. repositioning) Creates a treatment plan (i.e. 3-D models that represent the treatment plan). The treating dental practitioner reviews these images using software and has the option to reject or request modifications | Stand Alone Software Imports Digital Patient Scans Can be used to design Dental Models | Similar to Predicate | | Specification | Proposed Device: iOrtho | Predicate Device: 3Shape A/S Ortho System (K171634) | Reference Device: Wuxi EA Medical Instruments Technologies Limited. Clear Aligner (K203688) | Reference Device: Dentsply Sirona CEREC Ortho Software (K171122) | Comparison Result | | Minimum Hardware/Soft ware Requirements | • OS: Windows 7 )/Mac OS 10.12 • RAM: 2 GB • Video Card: Any that supports webGL • Hard Drive Space: 50MB • Web browser (iOrtho): Chrome 63+, Firefox 58+, Safari 12+, Edge 79+ • Internet Access | • OS: Windows 7, 8, 10 64-bit • RAM: 8 GB • Video Card Memory: 1 GB • Hard Drive Space: 250 GB • CPU: Intel Core i5 or equivalent • Mouse: with wheel button | • OS: Windows 7, 10, Mac OS X • RAM: 2 GB (minimum) • Hard Drive Space: 50 MB • Video Card: Graphics Display Card supporting webGL • Web Browser: Chrome 9+, Firefox 4+, Safari 5.1+, Edge 5.1+, IE11+ • Internet Access | • OS: Windows 7, 64-bit • RAM: 8 GB • Video Card Memory: 1 GB • Hard Drive Space: 250 GB • CPU: Intel QuadCore 1.6 GHz processor | Similar | | Login Method | Username and password | Username and password | Username and password | Unknown | Same | | Supported Anatomic Areas | Maxilla/Mandible | Maxilla/Mandible | Maxilla/Mandibl e | Maxilla/Mandib le | Same | | Intended Use | | | | | | | Specification | Proposed Device: iOrtho | Predicate Device: 3Shape A/S Ortho System (K171634) | Reference Device: Wuxi EA Medical Instruments Technologies Limited. Clear Aligner (K203688) | Reference Device: Dentsply Sirona CEREC Ortho Software (K171122) | Comparison Result | | Managing Patient and case base data | Yes | Yes | Yes | Yes | Same | | Collection of study material | Yes | Yes | Yes | Yes | Same | | Segmenting of study material (Segmenting gums/bone) | Yes — auto- segmented with manual adjustment | Yes — manual selection | Yes — manual selection | Yes — auto- segmented with manual adjustment | Similar | | Alignment of study material | Yes | Yes | Yes | Yes | Same | | Measuring study material | Yes | Yes | Yes | Yes | Same | | Measurement point selection | Automatic with manual adjustment | Manual selection | Manual selection | Automatic with manual adjustment | Similar | | Analyzing study material | Yes | Yes | Yes | Yes | Same | | Treatment simulation | Yes | Yes | Yes | N/A | Same | | Treatment Options | Up to unlimited number of stages | No limit on number of stages | Up to unlimited number of stages | N/A | Similar | | Virtual appliance design | Yes | Yes | Yes | Yes | Same | | Surface scan for intraoral scanner | Yes | Yes…

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