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510(k) Data Aggregation
K Number
K153177Device Name
Admira Fusion FlowManufacturer
Date Cleared
2016-06-30
(240 days)
Product Code
Regulation Number
872.3690Type
TraditionalPanel
DentalReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Admira Fusion Flow is intended for use as:
- Filling of small cavities and extended fissure sealing
- Blocking out undercuts
- Lining or coating cavities
- Fillings of class III V cavities
- Repairing fillings, veneers and temporary restorations
- Luting translucent prosthetic pieces
- Locking, splinting of loose teeth
Device Description
Not Found
AI/ML Overview
The provided text is a 510(k) summary for a dental device (Admira Fusion Flow) and does not contain information about acceptance criteria or a study proving its performance against such criteria. The document is an FDA clearance letter confirming substantial equivalence to a predicate device, along with the device's indications for use.
Therefore, I cannot extract the requested information regarding acceptance criteria and performance study details from this document.
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