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510(k) Data Aggregation
K Number
K955573Device Name
OPTIBLAST INTRAORAL SANDBLASTERManufacturer
Date Cleared
1996-05-03
(148 days)
Product Code
Regulation Number
872.6080Type
TraditionalPanel
DentalReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Not Found
Device Description
Not Found
AI/ML Overview
I am sorry, but based on the text provided, there is no information available regarding the acceptance criteria, study details, or performance of the "Optiblast Intraoral Sandblaster." The document is a 510(k) premarket notification letter from the FDA, confirming substantial equivalence to a predicate device and outlining regulatory requirements. It does not contain clinical study data, acceptance criteria, or performance metrics for the device itself.
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