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K Number
K993572
Device Name
CERADIUM V NON-PRECIOUS CERAMIC ALLOY
Manufacturer
MATECH, INC.
Date Cleared
1999-12-13

(53 days)

Product Code
EJH
Regulation Number
872.3710
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
  • Identification: A base metal alloy is a device composed of a material such as a Amixture of Nickel and Chromium
  • Intended Use: This material is to be used by the dentist in the fabrication of Ba custom-made dental device, such as a porcelain veneer for a tooth.
  • Classifcation: Class II C-
Device Description

Ceradium V Non-Precious Ceramic Alloy

AI/ML Overview

The provided document is a 510(k) clearance letter from the FDA for a dental alloy, Ceradium V Non-Precious Ceramic Alloy. This document does not contain any information about acceptance criteria or a study proving device performance. It only states that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information. The document focuses on regulatory clearance based on substantial equivalence, not on a detailed performance study with acceptance criteria.

§ 872.3710 Base metal alloy.

(a)
Identification. A base metal alloy is a device composed primarily of base metals, such as nickel, chromium, or cobalt, that is intended for use in fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Dental Base Metal Alloys.” The device is 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.