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510(k) Data Aggregation
K Number
K040043Device Name
NDX-40 ALLOYManufacturer
Date Cleared
2004-03-03
(51 days)
Product Code
Regulation Number
872.3060Type
TraditionalPanel
DentalReference & Predicate Devices
N/A
Why did this record match?
Device Name :
NDX-40 ALLOY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
¾ and single crowns, inlays, veneer crowns and short span bridges.
Device Description
Not Found
AI/ML Overview
This document is a 510(k) clearance letter from the FDA for a dental device called "NDX-40." It does not contain information about acceptance criteria, study design, or performance data beyond the device's indications for use. Therefore, I cannot generate the requested table and study details.
The document indicates:
- Device Name: NDX-40
- Indications For Use: "¾ and single crowns, inlays, veneer crowns and short span bridges."
- Regulation Number: 21 CFR 872.3060 and 21 CFR 872.5000 (Gold Based Alloys and Precious Metal Alloys for Clinical Use)
- Regulatory Class: II
- Product Code: EJT
To provide the information you requested, I would need a different document, such as the actual 510(k) summary or a clinical study report that details the performance testing of the NDX-40.
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