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K Number
K213149
Device Name
VOCO Retraction Paste
Manufacturer
Voco GmbH
Date Cleared
2021-12-09

(73 days)

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

For temporary retraction of the marginal gingiva to provide a dry gingival sulcus when the periodontium is healthy prior to, e.g - analogue or digital impressions - cementation of temporary and permanent restorations - preparation of class II and V fillings

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for a dental product called "VOCO Retraction Paste". This document does not contain any information about acceptance criteria or a study that proves a device meets acceptance criteria. Instead, it outlines the regulatory status of the device, its indications for use, and general regulatory requirements.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study based on the provided input. The details you are asking for, such as sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set information, and ground truth establishment, are not present in this regulatory clearance letter.

N/A