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K Number
K032316
Device Name
ORION E ALLOY
Manufacturer
DENTSPLY INTL.
Date Cleared
2003-09-30

(64 days)

Product Code
EJT
Regulation Number
872.3060
Type
Traditional
Panel
DE
Reference & Predicate Devices
K951787
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Fabricating crowns, bridges, precision milling bars or attachments, and crowns and bridges for porcelain fused to metal technique.

Device Description

ORION E ALLOY is a white high noble, gold-based dental alloy.

AI/ML Overview

The provided text describes a 510(k) summary for a dental alloy named "ORION E ALLOY" and the FDA's decision regarding its substantial equivalence. This document is a regulatory submission for a material device, not a software device or an AI/ML-driven diagnostic/assistive tool.

Therefore, the information requested regarding acceptance criteria, study design for AI/ML performance, sample sizes for test/training sets, expert involvement, and ground truth establishment is not applicable to this type of submission.

The document states:

  • "We believe that the prior use of the components of ORION E ALLOY in legally marketed devices, the performance data provided, and the historical use of the device in Europe support the safety and effectiveness of ORION E ALLOY for the indicated uses."
  • "This alloy has been on the European market since 1999 with over 40.000 units placed; the predicate device has been marketed since 1981. Therefore, it was determined that no biocompatibility testing was necessary."

This indicates that the "performance data" and "historical use" refer to established clinical use and material properties for dental alloys, rather than performance metrics of an AI model on a test set. The FDA's substantial equivalence determination is based on the new device having similar technological characteristics and intended use to a legally marketed predicate device (Degubond 4 alloy K951787), rather than performance against a set of statistical acceptance criteria derived from a study on diagnostic accuracy.

§ 872.3060 Noble metal alloy.

(a)
Identification. A noble metal alloy is a device composed primarily of noble metals, such as gold, palladium, platinum, or silver, that is intended for use in the fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.(b)
Classification. Class II (special controls). The special control for these devices is FDA's “Class II Special Controls Guidance Document: Dental Noble Metal Alloys.” The devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. See § 872.1(e) for availability of guidance information.