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510(k) Data Aggregation
K Number
K031439Manufacturer
Date Cleared
2003-10-02
(149 days)
Product Code
Regulation Number
872.3660Type
TraditionalPanel
Dental Devices (DE)Reference & Predicate Devices
N/A
Why did this record match?
Device Name :
ALGINATE IMPRESSION MATERIAL III (FAST & REGULAR)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Alginate Impression Material III (Fast & Regular Set) with water is used as dental impression material.
Device Description
Not Found
AI/ML Overview
This document is a 510(k) premarket notification from the FDA for an Alginate Impression Material III (Fast & Regular). It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information about acceptance criteria or a study proving that the device meets acceptance criteria.
Therefore, I cannot fulfill your request with the provided input. The document is a regulatory approval letter, not a technical report or study summary.
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