Who is the manufacturer of OnyxCeph?

Image Instruments GmbH filed the 510(k) submission for OnyxCeph (K213263).

What is the FDA product code for OnyxCeph?

LLZ. It is classified under 21 CFR 892.2050 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for OnyxCeph?

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

What are the predicate devices for OnyxCeph?

VISTADENT™ AT COMPLETE (K053010).

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

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.

OnyxCeph

K213263 · Image Instruments GmbH · LLZ · Jan 4, 2023 · Radiology

Device Facts

Record ID	K213263
Device Name	OnyxCeph
Applicant	Image Instruments GmbH
Product Code	LLZ · Radiology
Decision Date	Jan 4, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	Software as a Medical Device

Intended Use

OnyxCeph3™ is a software only device and is intended to be used for the medical purpose of manaqing and evaluating two-dimensional and threedimensional images in the framework of digital orthodontics by qualified staff only who have received dedicated training for use of the software. Diagnostic and therapeutic decisions cannot be motivated exclusively or even mainly on evaluation results provided by the software.

Device Story

OnyxCeph3™ is a Windows-based software for orthodontic and maxillofacial surgical planning. It ingests 2D images and 3D CT/DVT volume data. The software enables clinicians to perform metric and angular evaluations, cephalometric analysis, treatment simulation, and virtual model planning. Used in dental facilities by trained orthodontic staff, the software provides visual outputs for clinical review. It does not provide automated diagnostic or therapeutic decisions; clinicians use the output to support treatment planning. The device operates locally without requiring internet access, utilizing a key-based activation system. It benefits patients by facilitating precise, image-based orthodontic treatment planning and progress monitoring.

Clinical Evidence

No clinical data provided. Substantial equivalence is demonstrated through non-clinical software validation conducted in accordance with IEC 62304 standards.

Technological Characteristics

Windows-based software; local data storage; key-based activation; supports 2D/3D image import, cephalometric evaluation, treatment simulation, and volume segmentation. Complies with IEC 62304 for software life cycle processes.

Indications for Use

Indicated for qualified orthodontic staff to manage and evaluate 2D and 3D images for digital orthodontic workflows, including metric and angular evaluation of image data.

Regulatory Classification

Identification

A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Predicate Devices

VISTADENT™ AT COMPLETE (K053010)

Reference Devices

Ortho System™ (K171634)
NemoFAB (K192475)

Related Devices

K190162 — SmartCeph · Ortho2, LLC · Oct 17, 2019
K243005 — AudaxCeph Cephalogram Analysis Software · Audax D.O.O. · May 30, 2025
K161270 — CephSimulation · Anatomage, Inc. · Jan 4, 2017
K131570 — ORTHOVISION · Ewoosoft Co., Ltd. · Aug 15, 2013
K241819 — CephNinja · Cyncronus, LLC · Jan 23, 2025

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/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 acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square. January 4, 2023 Image Instruments GmbH % Greg Holland Sr. Partner Regulatory Specialists, Inc. 3722 Ave. Sausalito Irvine, California 92606 Re: K213263 Trade/Device Name: OnyxCeph3TM Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ, PNN Dated: November 30, 2022 Received: December 5, 2022 Dear Greg Holland: 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 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 {1}------------------------------------------------ 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, # Bobak Shirmohammadi -S For 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 Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K213263 Device Name OnyxCeph3TM #### Indications for Use (Describe) OnyxCeph*™ software is intended to be used for the medical purpose of managing and evaluating two-dimensional and three-dimensional images in the framework of digital orthodontics by qualified staff only. The use of OnyxCeph7™ 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. The software can be used to digitally perform certain image-based orthodontic workflows, such as metric and angular evaluation of image data. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------| | <div> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | #### 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}------------------------------------------------ ### 5. 510(k) Summary - K213263 | 510(k) Owner | Image Instruments GmbH Niederwaldstr. 3 09123 Chemnitz Germany Phone: +49 371 9093140 Facsimile: +49 371 9093149 | | OnyxCeph3 TM K213263 Subject Device | VISTADENTTM AT COMPLETE K053010 Predicate Device | | OnyxCeph3™ K213263 Subject Device | VISTADENT™ AT COMPLETE K053010 Predicate Device | |------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|-------------------------------------------|--------------------------------------------------------|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact person | Greg Holland Regulatory Specialists, Inc. 3722 Ave. Sausalito Irvine, CA 92606 Phone: 949.262.0411 Fax: 949.552.2821 Email: greg@regulatoryspecialists.com | Intended Use | Orthodontic Software | Orthodontic Software | Indications for Use | OnyxCeph3™ software is intended to be used for the medical purpose of managing and evaluating two- dimensional and three- dimensional images in the framework of digital orthodontics by qualified staff only. The use of OnyxCeph3™ 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. The software can be used to digitally perform certain image- based orthodontic workflows, such as metric and angular evaluation of image data. | VISTADENT™ AT COMPLETE software is a digital database for storing, retrieving and printing images that also has the ability to perform image manipulation and cephalometric analysis. | | Submission Date | January 3, 2023 | Product Code | LLZ | LLZ | | | | | Common Name Trade Name Classification Name Regulation Class Panel Primary Product Code Secondary Product Code | Orthodontic Software OnyxCeph3TM Radiological Image Processing System 892.2050 Class II Dental LLZ PNN | 2 Dimensional Image Import | Yes | Yes | | | | | Primary Predicate Device | K053010 VISTADENTTM AT COMPLETE From: Dentsply INTL., Inc. | 2 Dimensional Image Adjust | Yes | Yes | | | | | Reference Device | K171634 Ortho SystemTM From: 3Shape A/S K192475 NemoFAB From: Software Nemotec S.L. | | | | | | | ## Description OnyxCeph3™ dental aligner software device is designed for the simulation and planning of orthodontic and maxillofacial surgical combination treatments, based on virtual models and CT / DVT volume data. OnyxCeph3™ is a software device that includes both 3D and 2D versions both suitable for dental facilities to use for orthodontic treatments. {4}------------------------------------------------ #### Intended Use OnyxCeph3™ is a software only device and is intended to be used for the medical purpose of manaqing and evaluating two-dimensional and threedimensional images in the framework of digital orthodontics by qualified staff only who have received dedicated training for use of the software. Diagnostic and therapeutic decisions cannot be motivated exclusively or even mainly on evaluation results provided by the software. ### Indications for Use OnyxCeph3™ software is intended to be used for the medical purpose of manaqing and evaluating two-dimensional and three-dimensional images in the framework of digital orthodontics by qualified staff only. The use of OnyxCeph3™ 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. The software can be used to digitally perform certain image-based orthodontic workflows, such as metric and angular evaluation of image data. ## Technological Characteristics The predicates and the Image Instruments GmbH OnyxCeph3™ were compared in the following areas and found to have similar technological characteristics and to be equivalent. Both predicates are shown as a comparison in separate tables. {5}------------------------------------------------ {6}------------------------------------------------ | | OnyxCeph3™ K213263 Subject Device | VISTADENT™ AT COMPLETE K053010 Predicate Device | |----------------------------------------------|------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------| | 2 Dimensional Cephalometric Evaluation | Yes | Yes | | 2 Dimensional Image Combination | Yes | Yes | | 2 Dimensional Image Comparison | Yes | Yes | | 2 Dimensional Mirroring | Yes | Yes | | CO/CR- Conversion | Yes | Yes | | Ricketts VTO | Yes | Yes | | 2 Dimensional Treatment Simulation | Yes | Yes | | Windows Based | Yes | Yes | | Activation by Key | Yes | Yes | | Client Requirements | Hardware Type, CPU, RAM, Disk, Network, Graphic Board, Desktop Resolution | Hardware Type CPU, RAM, Disk, Network, Graphic Board, Desktop Resolution | | Client Requirements | Not Required | Internet Access, Internet Speed | | Server Requirements | Hardware Type, CPU, RAM, Disk, Network, Port Sharing | Hardware Type, CPU, RAM, Disk, Network, Port Sharing | {7}------------------------------------------------ | | OnyxCeph3™ K213263 Subject Device | Ortho System 3Shape A/S K171634 Reference Device | |----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use Indications | Orthodontic Software OnyxCeph3™ software is intended to be used for the medical purpose of managing and evaluating two-dimensional and three-dimensional images in the framework of digital orthodontics by qualified staff only. The use of OnyxCeph3™ 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. The software can be used to digitally perform certain image- based orthodontic workflows, such as metric and angular evaluation of image data. | Orthodontic Software The 3Shape Ortho System™ is intended for use as a medical front- end device providing tools for management of orthodontic 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. The use of the Ortho System™ 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. | | Product Code | LLZ | PNN | | | OnyxCeph3TM K213263 Subject Device | Ortho System 3Shape A/S K171634 Reference Device | | 2 Dimensional Evaluation | Yes | Yes | | 2 Dimensional Cephalometric Evaluation | Yes | No | | 3 Dimensional Evaluation | Yes | Yes | | Supported anatomical areas | Maxilla and Mandible | Maxilla and Mandible | | Determine arch shape | Yes | Yes | | Determine wire length | Yes | Yes | | Determine tooth width | Yes | Yes | | Determine Bolton | Yes | Yes | | Determine space analysis | Yes | Yes | | Determine overbite | Yes | Yes | | Determine occlusion | Yes | Yes | | Extract/Segment Volume Scans | Yes | Yes | | Combine Bony and Dental Scan Data | Yes | Yes | | Windows Based | Yes | Yes | | Data Storage | Local | Local / Cloud | | Activation by Dongle | No | Yes | | | OnyxCeph3™ K213263 Subject Device | Ortho System 3Shape A/S K171634 Reference Device | | Activation by Key | Yes | No | | Client Requirements | Hardware Type, CPU, RAM, Disk, Network, Graphic Board, Desktop Resolution | Hardware Type, CPU, RAM, Disk, Network, Graphic Board, Desktop Resolution | | Client Requirements | Not required | Internet Access, Internet Speed | | Server Requirements | Hardware Type, CPU, RAM, Disk, Network, Port Sharing | Hardware Type, CPU, RAM, Disk, Network, Port Sharing | {8}------------------------------------------------ {9}------------------------------------------------ Although the Indications for Use Statement for the subject device is different from the predicate device, K053010, the intended use of the software is the same, to allow for two-dimensional and three-dimensional evaluation of images. The predicate device includes Internet Access which is not required for the subject device. The subject device includes 3-dimensional evaluation capabilities; whereas the predicate device does not. However, the reference devices support this function. The reference device, K171634, was included to support the 3-dimensional evaluation capabilities of the subject device. This reference device does not include 2-Dimensional Cephalometric function, and activation by Key. However, the 2-Dimensional Cephalometric function is supported by the predicate device. The reference device offers activation by Dongle. In addition, the reference device supports the use of Data Storage via the Cloud and requires Internet Access whereas the subject device does not. Additional reference device, K192475 was included to support the devices intended use for supporting the treatment planning process of orthognathic procedures. In summary, the similarities between the subject device, OnyxCeph3™, and the predicate devices are functionally very similar. The differences identified do not raise different questions of safety and effectiveness as discussed in the table above. Nonclinical Testing Software Validation conducted per FDA Guidance for Software Contained in Medical Devices IEC 62304 - Software Life Cycle Processes #### Clinical Testing Clinical testing has not been included and is not required to demonstrate substantial equivalence. #### Conclusion Based on the similarities between the intended use, indications, principle of operation, features and technical data, the subject device, OnyxCeph3™, is found to be substantially equivalent to the predicate device.