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510(k) Data Aggregation
K Number
K042860Device Name
CORRECT DENTAL IMPRESSION MATERIALManufacturer
Date Cleared
2004-12-03
(49 days)
Product Code
Regulation Number
872.3660Type
TraditionalPanel
Dental Devices (DE)Reference & Predicate Devices
Why did this record match?
Device Name :
CORRECT DENTAL IMPRESSION MATERIAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Correct is used for all crown and bridge and implant impression techniques.
Device Description
Not Found
AI/ML Overview
The provided text is a 510(k) clearance letter from the FDA for a dental impression material named "Correct Dental Impression Material." It does not contain any information about acceptance criteria, device performance, study details, ground truth, or sample sizes.
Therefore, I cannot fulfill your request using the provided input. The document is solely a regulatory clearance for a medical device and does not describe any specific studies or performance metrics.
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