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K Number
K220743
Device Name
CediTEC
Manufacturer
VOCO GmbH
Date Cleared
2022-07-05

(113 days)

Product Code
EBI
Regulation Number
872.3760
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
  • Luting of prefabricated prosthetic teeth and CAD/CAM-produced individual teeth and tooth sections in CAD/CAMproduced denture bases
  • Luting of prosthetic teeth in the scope of a repair or extension
Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for a dental resin called CediTEC. It does not contain information about acceptance criteria or a study proving that a device meets those criteria. The document is primarily administrative, confirming that the device is substantially equivalent to legally marketed predicate devices and outlining regulatory requirements.

Therefore, I cannot provide the requested information based on the provided text.

§ 872.3760 Denture relining, repairing, or rebasing resin.

(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.