Search Results
Found 1 results
510(k) Data Aggregation
K Number
K103580Device Name
GRANDIO SO FLOWManufacturer
Date Cleared
2011-01-21
(46 days)
Product Code
Regulation Number
872.3690Type
SpecialPanel
DentalReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Grandio SO Flow is intended for use as:
- filling minimally invasive cavities of all classes -
- filling small class I cavities and extended fissure sealing -
- filling class II V cavities including V-shaped defects and cervical caries -
- blocking out undercuts -
- lining or coating cavities .
- repairing fillings and veneers -
- luting translucent prosthetic pieces (e.g., full ceramic crowns, etc.)
Device Description
Not Found
AI/ML Overview
I am sorry, but the provided text only contains an FDA 510(k) clearance letter for a dental material (Grandio SO Flow), which is a physical device, not an AI/ML-driven device. As such, the document does not contain information about acceptance criteria, study designs, sample sizes, expert qualifications, or ground truth establishment relevant to AI/ML device performance. Therefore, I cannot fulfill your request based on the given input.
Ask a Question
Ask a specific question about this device
Page 1 of 1