V-Print dentbase

• K Number: K220236
• Device Name: V-Print dentbase
• Manufacturer: Voco GmbH
• Date Cleared: 2022-09-21 ( 237 days)
• Product Code: EBI
• Regulation Number: 872.3760
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: N/A

Intended Use

Removable denture bases

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is an FDA 510(k) clearance letter for a dental device (V-Print dentbase) and outlines regulatory information and indications for use. It does not provide details about specific acceptance criteria for a study, performance metrics, sample sizes, expert qualifications, or study methodologies.

Regulation Number and Section

§ 872.3760 Denture relining, repairing, or rebasing resin.

(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.