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K Number
K042820
Device Name
SYSTEMP.C&B PLUS
Manufacturer
IVOCLAR VIVADENT, INC.
Date Cleared
2004-12-14

(63 days)

Product Code
EBG
Regulation Number
872.3770
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

For the fabrication of temporary crowns and bridges until the permanent restoration can be delivered.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) substantial equivalence determination letter from the FDA for a dental device called "Systemp.c&b Plus" (K042820). This type of document confirms that a new device is as safe and effective as a legally marketed predicate device.

Crucially, this document does NOT contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications for a medical device AI/ML model.

Instead, it's a regulatory approval letter for a temporary crown and bridge resin, a material used in dentistry, not a diagnostic or AI-powered device. The content focuses on regulatory compliance, legal marketing, and general controls provisions of the Act.

Therefore, I cannot provide the requested information based on the provided text. The questions are relevant to the evaluation of AI/ML medical devices, which this document does not describe.

§ 872.3770 Temporary crown and bridge resin.

(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.