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K Number
K973257
Device Name
VERSAETCH
Manufacturer
CENTRIX, INC.
Date Cleared
1997-11-17

(80 days)

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

Touth etchant And conditioners to took surface for Second's, then Rinse off 20 Proceed to Apply water. specific manda Agents As per INSTRUctions,

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) clearance letter from the FDA for a device named "Versa Etch." It primarily details the regulatory approval process and states that the device is substantially equivalent to legally marketed predicate devices.

However, the document does not contain any information regarding specific acceptance criteria, performance data, or study details such as sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies. It is a regulatory approval notice, not a technical performance report.

Therefore, I cannot provide the requested information based on the input document.

§ 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.