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K Number
K052820
Device Name
PARAPOST PARACORE AUTOMIX 5ML
Manufacturer
COLTENE/WHALEDENT AG
Date Cleared
2006-01-09

(97 days)

Product Code
EBF
Regulation Number
872.3690
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

ParaPost ParaCore automix 5ml is indicated for core build-ups and cementation of posts

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA to Coltene/Whaledent AG regarding their device, ParaPost ParaCore Automix 5ml. This document primarily focuses on the FDA's determination of substantial equivalence to a predicate device and provides regulatory guidance.

It does not contain any information about acceptance criteria for device performance, study details, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or other study-related details based on the provided text.

§ 872.3690 Tooth shade resin material.

(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.