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K Number
K013609
Device Name
NEXUS 2 CLEAR
Manufacturer
SYBRON DENTAL SPECIALTIES, INC.
Date Cleared
2002-01-16

(77 days)

Product Code
EMA
Regulation Number
872.3275
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Nexus 2 Clear is a dual cured, resin-based, dental cement designed to be used for luting inlays, onlays, crowns, bridges, porcelain veneers and endodontic posts.

Device Description

Nexus 2 Clear is a dual cured, chemical and light cured, dental cement designed to be used for luting inlays, onlays, crowns, bridges, porcelain veneers and endodontic posts. Nexus 2 Clear is a two-part, base/catalyst - paste/paste, system.

AI/ML Overview

This document is a 510(k) premarket notification for a dental luting cement, Nexus 2 Clear. It does not contain information on acceptance criteria for a device's performance, nor does it describe a study proving such criteria are met. The document focuses on establishing substantial equivalence to a predicate device based on similar materials, intended use, and functional characteristics, which is a regulatory pathway, not a performance study as typically understood for AI/ML or diagnostic devices.

Therefore, I cannot provide the requested information. The document pertains to a traditional medical device (dental cement) and its regulatory submission, not a study evaluating a device's performance against pre-defined acceptance criteria in the context of clinical outcomes or AI model accuracy.

§ 872.3275 Dental cement.

(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.