(31 days)
CHROMA ZONE COLOR STAIN is designed to be used for developing color characterization for resin-based:
- Facing crown
- Jacket crown
- Inlay and Onlay
CHROMA ZONE COLOR STAIN is classified into tooth shade resin material, CFR 21 Section 872.3690, because it is a device composed of materials such as dimethacrylate monomers and inorganic fillers intended to be used for laboratory fabrication of jacket crown, facing crown, inlay and onlay restorations.
The provided document is a 510(k) summary for a dental product called "CHROMA ZONE COLOR STAIN." This document pertains to a regulatory submission for a medical device and does not contain information about studies proving the device meets acceptance criteria in the context of an AI/ML medical device.
The 510(k) summary is primarily concerned with establishing substantial equivalence to a predicate device for regulatory purposes. It explicitly states: "The aim of 510(k) submission is to alter the name and address of manufacturer, and not to intend other changes" and "Therefore the technological characteristics, chemical ingredients and safety of this device are completely the same as CHROMA ZONE COLOR STAIN manufactured by Kuraray Co., Ltd. (K982259)."
Consequently, I cannot extract the requested information about acceptance criteria and study details for an AI/ML device from this document. The document describes a conventional dental material, not an AI-powered diagnostic or therapeutic device.
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.