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510(k) Data Aggregation
K Number
K073047Device Name
APROXI 1100 AND 4000 SERIES DENTAL INLAYSManufacturer
Date Cleared
2008-08-07
(283 days)
Product Code
Regulation Number
872.3690Type
AbbreviatedPanel
DentalReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Inlays for Class II fillings
Device Description
Not Found
AI/ML Overview
I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA regarding dental inlays. It discusses the substantial equivalence of the Aproxi 1100 and 4000 Series Dental Inlays to legally marketed predicate devices.
The letter does not contain any information about:
- Acceptance criteria for a device's performance.
- A study proving the device meets acceptance criteria.
- Sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details.
Therefore, I cannot fulfill your request based on the provided text.
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