NemoFAB

Primary DI
08437023642023
Brand
NemoFAB
Company
SOFTWARE NEMOTEC SL
Model
25.0.0.2
Device description
The NemoFAB software is a tool designed for use by specialized dental practices and surgeons for capturing, storing and presenting patient images and supporting the diagnostic process and virtual treatment planning in Orthognathic Surgery procedures.NemoFAB has specific functionalities to visualize the diagnostic information, e.g. from CT-imaging, to perform specific measurements in the image data and to plan surgical actions in order to support the diagnostic and treatment planning process.Based on the CT or CBCT of the skull and the models of the teeth of the patient, the user (an oral and maxillofacial surgeon) designs the treatment plan, moving the osteotomized bones to the appropriate location to fix the bite, the face and/or any other deformities.The module allows the user to import the dental casts in STL format (from a laboratory scanner or intraoral scanner) and merge them to the CT of the patient; this process is necessary if a splint is going to be created. The airway of the patient can be segmented from the CT for analysis purpose and the TMJ (temporomandibular joint) can be studied for supporting the diagnose. Several types of osteotomies are supported: Le Fort 1, Sagittal split, Ramus and Chin.The Arnett/Gunson cephalometric tracing allows the surgeon to have accurate measurements information about the position of the anatomical structures and the extent of the movements; ceph tracing allows the user to digitize anatomical landmarks on a patient’s DICOM (in 3D) or radiograph (in 2D). Arnett/Gunson FAB Cephalometric Analysis performs face, airway and bite analysis, and allows to simulate a treatment plan for orthodontic and surgical cases based on the methodologies of Dr. William Arnett. If the user does not want to follow the protocol of Dr. Arnett, a manual way treatment plan can be simulated. The knowledge of the surgical positions allows this module to create splints for aiding the surgeon in the placement of the bones in the surgery.
Published
2026-04-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192475000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192475000NemoFABSoftware Nemotec S.L.2020-04-23LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08437023642023PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08437023642023084370236420238437023642023

GMDN Terms#

Term, Definition table
TermDefinition
Dental treatment application softwareAn application software program intended to facilitate dental treatment, which may include dental implant and/or oral/maxillofacial surgery planning, by storing/displaying patient demographics/clinical data and treatment plans, and may control settings for dental equipment (e.g., a line-powered dental drilling system). It is typically for installation in an off-the-shelf desktop, laptop or tablet computer, which may require a connection to the dental equipment. It typically includes upgrades to the software.

Contacts#

Phone, Email table
PhoneEmail
+34914335222support@nemotec.com

Regulatory Flags#

DUNS number
478013956
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08437023642016NemoCast25.0.0.22026-04-23
08437023642047NemoScan25.0.0.22026-04-23

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