Search Results

ParaCem Universal DC is indicated for cementing of endodontic posts, crowns, bridges, inlays, onlays, veneers and for core build-ups

Not Found

This document is a 510(k) premarket notification letter from the FDA regarding a dental cement called "ParaCem Universal DC." It confirms substantial equivalence to a predicate device and permits marketing. However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

Therefore, I cannot provide the requested information. The document focuses solely on the regulatory clearance process for a medical device and doesn't delve into the detailed technical studies that would typically be performed to establish performance claims.

Ask a specific question about this device