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510(k) Data Aggregation
K Number
K013769Device Name
V-GNATHOS SUPRAManufacturer
Date Cleared
2002-01-22
(70 days)
Product Code
Regulation Number
872.3060Type
TraditionalPanel
DentalReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Substructures for porcelain-to-metal crowns and bridges. Suprastructures on implants, milling works."""
Device Description
Not Found
AI/ML Overview
The provided text is a 510(k) premarket notification letter from the FDA to Metalor Technologies USA Dental Division regarding their device, V-Gnathos Supra. This document primarily focuses on the regulatory approval process and does not contain information about acceptance criteria or a study that proves the device meets those criteria.
Therefore, I cannot provide the requested information based on the given input. The document is a regulatory approval letter, not a study report.
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