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510(k) Data Aggregation
K Number
K192701Device Name
DIBS (Digital Indirect Bonding System)
Manufacturer
Date Cleared
2020-04-21
(207 days)
Regulation Number
872.5470Why did this record match?
Applicant Name (Manufacturer) :
OrthoSelect, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
DIBS by OrthoSelect 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 (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 DIBS by OrthoSelect 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.
Device Description
DIBS by OrthoSelect is a software system used for the management of 3D scanned orthodontic models of the patients' dentition and allows orthodontic measurements, analysis, inspection, and visualization. The primary purpose of DIBS is to allow virtual planning of orthodontic treatments by simulating tooth movements, virtual placement of orthodontic brackets, and design of orthodontic appliances based on the 3D scanned orthodontic models. Output includes STL files that can be used to make Indirect Bonding Transfer Trays (also called orthodontic bracket placement trays). The device has no patient contact. DIBS is a software-only device.
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