K Number
K160086
Date Cleared
2016-07-21

(188 days)

Product Code
Regulation Number
872.3690
Panel
DE
Reference & Predicate Devices
N/A
Predicate For
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Etching of natural enamel

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) clearance letter from the FDA for a dental product called "Shofu Enamel Conditioner." This letter does not include information about acceptance criteria, device performance studies, or details relevant to artificial intelligence (AI) device evaluations.

The document is a regulatory approval notice for a physical dental product (an enamel conditioner), not a software or AI-driven medical device. Therefore, the information requested in your prompt (e.g., sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance, ground truth methods) is not present in this type of document.

The "Indications for Use" section (page 2) simply states "Etching of natural enamel" as the intended use of the product. No performance metrics or study details are provided.

§ 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.