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510(k) Data Aggregation
K Number
K190453Device Name
VisCalor bulkManufacturer
Date Cleared
2019-04-11
(45 days)
Product Code
Regulation Number
872.3690Type
SpecialPanel
DentalPredicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
- Class I and II posterior restorations
- Base in class I and II cavities
- Class V restorations
- Locking, splinting of loose teeth
- Repairing veneers, enamel defects and temporary C&B-materials
- Extended fissure sealing
- Restoration of deciduous teeth
- Core build-up
Device Description
Not Found
AI/ML Overview
The provided text is a 510(k) clearance letter for a dental device called VisCalor Bulk. It contains information related to the device's indications for use and regulatory classification. However, it does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.
Therefore, I cannot provide the requested information. The text is a regulatory document and not a clinical study report or technical specification document detailing performance metrics.
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