Search Results
Found 1 results
510(k) Data Aggregation
K Number
K051535Device Name
MODIFICATION TO:REGISTRADO X-TRAManufacturer
Date Cleared
2005-06-28
(18 days)
Product Code
Regulation Number
872.3660Type
SpecialPanel
DentalReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Registrado X-tra is suitable for bite registration. fixing of face bow registration and is a location material for intra-oral pin tracing template
Device Description
Not Found
AI/ML Overview
This document is a marketing clearance letter from the FDA for a dental impression material called "Registrado X-tra". It does not contain information about acceptance criteria or a study that proves the device meets those criteria. Such information would typically be found in the 510(k) premarket notification summary, which this document references but is not.
Therefore, I cannot provide the requested information based on the provided text.
Ask a Question
Ask a specific question about this device
Page 1 of 1