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510(k) Data Aggregation
K Number
K221478Device Name
Dolphin Blue Imaging
Manufacturer
Patterson Dental Supply, Inc.
Date Cleared
2022-11-01
(162 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Patterson Dental Supply, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Dolphin Blue Imaging 2.0 software is designed for use by specialized dental practices for capturing, storing and presenting patient images and assisting in treatment planning and case diagnosis. Results produced by the software's diagnostic and treatment planning tools are dependent on the interpretation of trained and licensed practitioners.
Device Description
Dolphin Blue Imaging 2.0 software is designed for use by specialized dental practices for capturing, storing and presenting patient images and assisting in treatment planning and case diagnosis. Results produced by the software's diagnostic and treatment planning tools are dependent on the interpretation of trained and licensed practitioners.
Dolphin Blue Imaging 2.0 is a software that provides imaging, diagnostics, and case presentation capabilities for dental specialty professionals. The Dolphin Blue Imaging 2.0 suite of software products is a collection of modules that together provide a comprehensive toolset for the dental specialty practitioner. Users can easily manage 2D images and x-rays; accurately diagnose and treatment plan, quickly communicate and present cases to patients and can work efficiently with colleagues on multidisciplinary cases. The below functionalities make up the medical device modules:
Tracing Module
Measurements Module
Superimpositions Module
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K Number
K110430Device Name
DOLPHIN IMAGING
Manufacturer
PATTERSON DENTAL SUPPLY, INC.
Date Cleared
2011-05-11
(86 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
PATTERSON DENTAL SUPPLY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Dolphin Imaging software is designed for use by specialized dental practices for capturing, storing and presenting patient images and assisting in treatment planning and case diagnosis. Results produced by the software's diagnostic and treatment planning tools are dependent on the interpretation of trained and licensed practitioners.
Device Description
The software contains eight major components (modules) for achieving its basic functionalities. They are ImagingPlus™, Ceph Tracing, Treatment Simulation, Arnett/Gunson FAB, McLaughlin Dental VTO, Impanner™, Dolphin 3D, and Dolphin Letter System.
ImagingPlus™ is the foundation of the Dolphin product suites. It allows the user to capture, organize, edit, print, store and present patient image records.
Ceph Tracing allows the user to digitize landmarks on a patient's radiograph, trace cephlometric structures, view cephalometric measurements, and superimpose images for analysis.
Treatment Simulation (VTO) Module provides a tool to simulate orthodontic and surgical treatment results using Visual Treatment Objective (VTO).
Amett/Gunson FAB Analyses performs face, ainway, bite analysis, and simulate treatment for orthodontic and surgical cases based on the methodologies of Dr. William Arnett.
The McLaughlin Dental VTO is an interactive treatment-planning and case presentation software program based on the theories of Dr. Richard P. McLaughlin, a renowned clinician, author and lecturer. It analyzes and evaluates tooth positions and dental treatment options, which assists clinicians in planning precise, quantifiable movement of dentition using clinical examination and treatment planning values.
Dolphin Implanner Module is for planning implant procedures. Using this module, simulated dental implants can be placed on a patient's lateral or panoramic x-ray images.
The Dolphin 3D module contains features for generating a multitude of views of the volumetric data, including simulated x-ray views and 3D-rendered views of the volume.
Dolphin Letter System generates letters that include the images and diagnostic questionnaire data entered by the user can choose a pre-defined letter template or create a custom template.
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